Source: http://www.readbag.com/accessdata-fda-cdrh-docs-pdf7-k073285
Timestamp: 2019-08-23 12:17:45
Document Index: 176640050

Matched Legal Cases: ['arts 800', 'art 807', 'art 801', 'art 820', 'art 801', 'art 807', 'art 21']

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MAY 1 5 20DO
MEDTRONIC Sofamor Danek PEEK PREVAIL TM' Cervical Interbody Device February 2008
I. Company: Medtronic Sofamor Danek, Inc. 1800 Pyramid Place Memphis, Tennessee 38132
(901) 396-3133 II. Product Name:
Common Name: Classification:
PEEK PREVAILTM Cervical Interbody Device
Interbody Fusion Device 21 CFR 888.3080 - Product Code: MAX
Description: The PEEK PREVAILTM Cervical Interbody Device is an
intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is &quot;I-Beam&quot; shaped with a 2 screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with autograft.
The PEEK PREVAILT M Cervical Interbody device implant is manufactured from PEEK Optima® and contains tantalum radiopaque markers and a Nitinol screw locking mechanism. The screws used with this device (ZEPH!R® Anterior Cervical Screws) are manufactured from Titanium Alloy.
Indications for Use: The PEEK PREVAILTM Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-TI disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAILTM Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAJLTM Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Substantial Equivalence: Documentation was provided which demonstrated that the PEEK PREVAILTM Cervical Interbody Device components are substantially equivalent to previously approved devices such as the previously approved AFFINITY® Anterior Cervical Cage (P000028, Approved - 06/13/2002), the BAK/C® Cervical Interbody Fusion System (P980048, Approved - 04/20/200 1), VERTE-STACK® Spinal System (K070173, S.E. 3-14-2007 and K062073, S.E. 8-14-2007), and the VENTURE T M Anterior Cervical Plate System (K061274, S.E. 05-25-2006).
MAY 1 5 2008
Medtronic Sofamor Danek, Inc. % Mr. Michael Scott 1800 Pyramid Place Memphis, TN 38132 Re: K073285 Trade/Device Name: PEEK PREVAILTM Cervical Interbody Device Regulation Number: 21 CFR 888.3080 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: ODP Dated: May 7, 2008 Received: May 9, 2008
Dear Mr. Scott: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Page 2 - Mr. Michael Scott
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (2.40) 276-0120. Also, please note the regulation entitled, &quot;Misbranding by reference to premarket notification&quot; (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours,
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Device Name: PEEK PREVAILTM Cervical Interbody Device Indications for Use: The PEEK PREVAILTM Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAILTM Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAILTM Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment. Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(Division Sign-Offi -Division of General, Restorative, and Neurological Devices 510 (k)Numbe riP_7__ i