32 orthopedic, spine devices receive FDA 510(k) clearance in November

Written by Laura Dyrda | December 17, 2015 | Print  |

The Food and Drug Administration cleared 32 orthopedic and spine devices in November.

1. Humelock II Reversible Shoulder System from FX Solutions.

 

2. Waston General Spinal System from Changzhou Watson Medical Appliance.

 

3. Redapt Porous Acetabular Shell and Cemented Liner from Smith & Nephew.

 

4. PainKARE from TrioWave Technologies.

 

5. AVAflex Vertebral Balloon System from CareFusion.

 

6. Kyphon Xpede Bone Cement from Medtronic.

 

7. Revision Femoral Stem from Lima Corporate.

 

8. Libra Pedicle Screw System from Spinal Balance.

 

9. Concorde Bullet Lumbar Interbody System from Medos International.

 

10. Integrity Spine Lumbar Interbody Fusion System from Integrity Spine Lumbar Interbody.

 

11. Polaris Spinal System from Biomet Spine.

 

12. FastFrame External Fixation System from Zimmer.

 

13. SMV Scientific Bone Plate and Screw System from SMV Scientific.

 

14. Renaissance X System from Mazor Robotics.

 

15. KATOR Suture Anchor form KATOR.

 

16. G3 Active Plate from Large Fragment System from Genesis Fracture Care.

 

17. CD Horizon Spinal System from Medtronic Sofamor Danek USA.

 

18. Arthrex iBalance TKA System from Arthrex.

 

19. BoneCam Suture Anchors from Valeris Medical.

 

20. InFill Interbody Fusion Device from Pinnacle Spine Group.

 

21. PIVOX Oblique Lateral Spinal System from Medtronic Sofamor Danek.

 

22. Cam Lock Plating System from Life Spine.

 

23. Talon DistalFix Antegrade/Retrograde Femoral Nail from Orthopedic Designs North America.

 

24. Evolution BioFoam Tibial Base from Microport Orthopedics.

 

25. Tritanium PL Cage from Stryker.

 

26. Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments from Zimmer.

 

27. Atlantis Anterior Cervical Plate System from Medtronic Sofamor Danek.

 

28. SIGN Hip Construct from Sign Fracture Care.

 

29. Zimmer Plates and Screws System Sterile 2.7mm Cortical Screws form Zimmer.

 

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

 

31. Arthrex Universe Apex, Size 5 Stem from Arthrex.

 

32. Tyber Medical MST Trauma Screw from Tyber Medical.

 

More articles on FDA clearances:
39 spine, orthopedic devices receive FDA 510(k) clearance in October
42 spine, orthopedic devices receive FDA 510(k) clearance in September
39 spine, orthopedic devices receive FDA 510(k) clearance in August

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