35 orthopedic devices receive FDA 510(k) clearance in September

Spinal Tech

The FDA granted 35 orthopedic- and spine-related device clearances in September.

 

1. OMNIBotics Knee System from OMNIlife Science.

 

2. Shanghai Sanyou PEEK Cage System from Shanghai Sanyou Medical.

 

3. Ecofit Hip System from Implantcast.

 

4. Shotel Ankle Arthrodesis Nail System from BioPro.

 

5. Calix Lumbar Spinal Implant System from X-Spine.

 

6. Independence Spacers from Globus Medical.

 

7. Arthrex Mesh Plate System from Arthrex.

 

8. Arix Wrist System from Jeil Medical.

 

9. Elements Image Fusion, Elements Spine Curvature Correction from Brainlab.

 

10. T-Rex Standalone ALIF from SIATS.

 

11. Viper Prime navigated inserter from Medos International.

 

12. Invision Total Ankle Revision System from Wright Medical Technology.

 

13. Capstone Control Spinal System from Medtronic Sofamor Danek.

 

14. OIC External Fixation System from Orthopaedic Implant Company.

 

15. Posterior Spine Truss System Interbody Fusion Device from 4Web.

 

16. Tritanium C Anterior Cervical Cage from Stryker Spine.

 

17. FLXfit from Expanding Orthopedics.

 

18. Neo Pedicle Screw System from Neo Medical.

 

19. NuVasive TLX Interbody System form NuVasive.

 

20. Choice Spine Hawkeye Vertebral Body Replacement System from Choice Spine.

 

21. Range/Denali/Mesa Spinal System from K2M.

 

22. Darco Locking Bone Plate System from Wright Medical Technology.

 

23. NuVasive Precept Spinal System from NuVasive.

 

24. Scarlet AC-T from Spineart.

 

25. Matira Anterior Cervical System from Kalitec Direct.

 

26. Romeo 2 Posterior Osteosynthesis System from Spineart.

 

27. Elevate Spinal System, Capstone PTC Spinal System, Crescent Spinal System from Medtronic Sofamor Danek.

 

28. Mako Total Knee Application from Mako Surgical.

 

29. Vitality Spinal Fixation System, Vitality Power Instrument System form Zimmer Biomet Spine.

 

30. PMT Posterior Fixation System from Providence Medical Technology.

 

31. Reliance Cervical IBF System from Reliance Medical Systems.

 

32. iNSitu Total Hip System from Theken Companies.

 

33. Mazor X from Mazor Robotics.

 

34. Medacta-C with titanium markers and Medacta-C TiPEEK with titanium markers from Medacta.

 

35. Precice System from NuVasive.

 

More articles on orthopedic devices:

57 orthopedic devices receive FDA 510(k) clearance
33 orthopedic devices receive FDA 510(k) clearance in July
48 orthopedic devices receive FDA 510(k) clearance in June

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