Source: http://docplayer.net/16938370-July-24-2015-dear-ms-rhodes.html
Timestamp: 2019-10-23 06:04:13
Document Index: 764230627

Matched Legal Cases: ['arts 800', 'art 807', 'art 801', 'art 820', 'art 801', 'art 803']

July 24, Dear Ms. Rhodes: - PDF
July 24, Dear Ms. Rhodes:
Download "July 24, 2015. Dear Ms. Rhodes:"
1 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD InnoVision, Incorporated Ms. Hollace Saas Rhodes Director, Orthopedic Regulatory Affairs 1331 H Street NW, 12 th Floor Washington, District of Columbia July 24, 2015 Re: K Trade/Device Name: N-Force Fixation System Regulation Number: 21 CFR Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 28, 2015 Received: April 29, 2015 Dear Ms. Rhodes: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2 Page 2 Ms. Hollace Saas Rhodes forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections of the Act); 21 CFR If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) or (301) or at its Internet address Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR Part ). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to for the CDRH s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) or (301) or at its Internet address Sincerely yours, Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure
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4 Page 1 of 2 510(k) Summary Manufacturer: Device Trade Name: Common Name: InnoVision, Inc Nonconnah Boulevard Memphis, TN N-Force Fixation System Smooth or threaded metallic bone fixation fastener Date Prepared: April 28, 2015 Prepared By: Musculoskeletal Clinical & Regulatory Advisers, LLC 1331 H Street NW, 12 th Floor Washington, DC Device Trade Name: N-Force Fixation System Classification: Class: Product Code: 21 CFR , Smooth or threaded metallic bone fixation fastener II HWC Indications for Use: The N-Force Fixation System is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver injectable bone void fillers to a surgical site. Device Description: The N-Force Fixation System includes fully and partially cannulated screws in various diameters and lengths, in both fenestrated and non-fenestrated options. The system also includes washers and accompanying instruments. The N-Force Fixation System implants are made of titanium alloy. Page 7
5 Page 2 of 2 Predicate Device: The N-Force Fixation System is substantially equivalent to the predicate N-Force Fixation System (K102528, K132244) with respect to indications, design, function, performance, materials and its ability to deliver BVFs to a surgical site. Substantial Equivalence: Testing performed on the N-Force Screw indicates that it is substantially equivalent to the predicate devices. Mechanical testing of the screw included static three-point bending, torsion, axial pull-out, and insertion torque. Bone void filler injection testing included injectability, experimental void fill imaging, relative paste hardness, X-Ray diffraction, and static extraction torque. Page 8