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

Spinal Tech

The FDA cleared 33 orthopedic- and spine-related devices in September.

 

1. External Fixation System from Life Spine.

2. MicroPort Orthopedics Total Hip Systems MR Labeling from MicroPort Orthopedics.

3. Sorrento Bioglass Bone Graft Substitute from Xenco Medical.

4. DePuy Corail AMT Hip Prosthesis from DePuy France.

5. Fortify Corpectomy Spacers from Globus Medical.

6. Dyna-Link Elite Stand-Alone Anterior Lumbar System from Life Spine.

7. Spinal Elements Cerclage System from Spinal Elements.

8. Libertas Hip Replacement System from Maxx Orthopedics.

9. Corin Optimized Positioning System (OPS) Femoral from Corin.

10. TirboLOX-C Cervical IBFD from Captiva Spine.

11. Prodense Bone Graft Substitute from Wright Medical Technology.

12. T2 Stratosphere Expandable Corpectomy System from Medtronic Sofamor Danek.

13. Redapt Porous Acetabular Shell.

14. LnK Lumbar Interbody Fusion Cage System from L&K Biomed.

15. Response Spine System from OrthoPediatrics.

16. Aequalis Flex Revive Shoulder System from Tornier.

17. Exactech Alteon Monobloc Revision Stem from Exactech.

18. Prime E-CLASS XLPE Liner from MicroPort Orthopedics.

19. Comprehensive Reverse Shoulder System from Biomet Manufacturing.

20. Renovis S180 Lateral Lumbar Interbody Fusion System from Renovis Surgical Technologies.

21. Tranquil-L Interbody System from Nexus Spine.

22. ReUnion Reversible Fracture System, Shoulder Arthroplasty System from Stryker.

23. Microraptor Knotless Suture Anchor from Smith & Nephew.

24. Arthrex FiberTak Suture Anchor from Arthrex.

25. Truliant Porous Femoral Components from Exactech.

26. Moss VRS Spinal System from Biedermann Motech.

27. OsseoScrew System from Alphatec Spine.

28. Chiral Surgical Pedicle Screw System from Chiral Surgical.

29. Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay from Arthrex.

30. Spineology Navigation Instruments from Spineology.

31. Acculoc Total Knee System from RootLoc.

32. CarboClear Pedicle Screw System from CarboFix Orthopedics.

33. CoLink View Plating System from In2Bones USA.

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