Document ID: chunk:federal_register_of_legislation:F2024L01386:schedule:1:p523
Version: federal_register_of_legislation:F2024L01386
Segment Type: schedule
Provision Reference: sch 1 (pt 523/696)
Character Range: 16894372–16937240

System-Pedicle Screw, Polyaxial                                                  Ulrich Pedicle Screw System (uCentum)-Pedicle Screw, Polyaxial, standard or long arm, sterile or non-sterile                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          dia (4.5-10 mm) x length (25-60 mm)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       $996.00
ER446                                                                            LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System-Pedicle Screw, polyaxial                  LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System-Pedicle Screw; polyaxial; self tapping or non self tapping; standard or reduction; accommodates rods of 5.0, 5.5, 6.0 and 6.35mm in diameter                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              dia (4.0-8.5mm) x length (20-150mm)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       $996.00
ER662                                                                            LnK AccelFix Spinal Fixation System-polyaxial screw                                                   AccelFix S/AccelFix DS/AccelFix SS polyaxial screws, sterile, single or double lead, standard or variable pitch, closed or open, Ti, sterile                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Diameter: 4-8,5 mm  Length: 34.2-176.5 mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 $996.00
ER310                                                                            Ulrich posterior OCT System (neon3)-Pedicle Screws                                                    Ulrich posterior OCT System (neon3)-Pedicle Screws, non-cannulated, lateral mass screws                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               dia (3.5-4 mm) x length (10-28 mm)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        $996.00
ER512                                                                            e.Spine PEDICULAR SCREW                                                                               spine Pedicular Screw for sacral-thoraco-lumbar osteosynthesis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Pedicle or Reduction pedicle;                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             $996.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Diameter 4.35 Length 25 to 55 mm,
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Diameter 5 Length 25 to 60 mm,
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Diameter 6 Length 25 to 65 mm,
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Diameter 6.5 Length 25 to 70 mm,
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Diameter 7 Length 30 to 80 mm.

     EQUINOX MEDICAL PTY LTD
GW027                                                                            WEGO Spinal Systems                                                                                   Polyaxial screws                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      All sizes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 $996.00

     EVOLUTION SURGICAL PTY LTD
IY083                                                                            Life Spine Pedicle Screw System - Pedicle Screw, Polyaxial                                            Life Spine Pedicle Screw System (Nautilus) - Pedicle Screw, Polyaxial Standard or Reduction                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           dia (4.5-8.5mm) x length (25-125mm)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       $996.00
IY005                                                                            BA Posterior Screw                                                                                    Polyaxial Screw                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Ø3.5, Ø4.0, Ø4.5  8mm to 50mm in length.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  $996.00

     Globus Medical Australia Pty Limited
LB090                                                                            CREO Stabilization System Preassembled Polyaxial Screw                                                The CREO Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation or anterolateral fixation.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     4.0mm diameter to 10.5mm diameter                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         $996.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             20mm to 120mm length
LB130                                                                            CREO MCS - Polyaxial Screw                                                                            Pre-assembled dual outer diameter polyaxial screw                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Diameter: 5.0- 6.5 mm, Length 20-45mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     $996.00
LB080                                                                            REVERE TRANSITION HA coated Pedicle Screw                                                             Polyaxial Screw HA Coated, Dual Outer Diameter, Prefered Angle                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        5.5mm-8.5mm x 35mm - 100mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                $996.00
LB079                                                                            REVERE Polyaxial Screw                                                                                Polyaxial screw                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       5.5 Titanium, Alloy and Stainless Steel- 4.0-8.5mm x 20mm to 90mm in 5mm increments                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       $996.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             5.5 Reduction screws - 5.5mm-7.5mm x 30mm-90mm in 5mm increments
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             6.35 Titanium Alloy and Stainless Steel - 5.5mm - 90mm x 25mm to 120mm in 5mm increments
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             5.5 Dual Diameter Screw Titanium Alloy and Stainless Steel - 5.5mm, 6.0mm 7.0mm, 7.5mm x 30mm to 100mm in 5mm increments
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             6.35 Dual Diameter Screws Titanium Alloy and Stainless Steel - 5.5mm, 6.0mm, 7.0mm, 7.5mm x 30mm to 65mm in 5mm increments
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             4.0-8.0mm diameter 20-90mm length
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             4.5 - 6.5mm diameter uniplanar fracture reduction screws, 25-55mm in 5mm increments
LB043                                                                            ELLIPSE Stabilization System, Polyaxial Screw                                                         Polyaxial Bone Screw                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  3.5mm - 4.5mm diameter 8mm x 50mm length                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  $996.00
LB153                                                                            QUARTEX