33 spine, orthopedic devices receive FDA 510(k) clearance in December

Written by Laura Dyrda | January 19, 2016 | Print  |

The Food and Drug Administration cleared 33 orthopedic- and spine-related devices in December 2015.

1. Spinal Inner Fixation System from Changzhou Dingjian Medical Application.

 

2. FIREFLY Pedicel Screw Navigation Guide from Mighty Oak Medical.

 

3. ROSA Brain from Medtech.

 

4. Intellijoint Hip System from Intellijoint Surgical.

 

5. Sahara Stabilization System from K2M.

 

6. Latitude-C Cervical Interbody Spacer System from Degen Medical.

 

7. VariLift-L Interbody Fusion Device from Wenzel Spine.

 

8. RIO-C Titanium-Coated Implant System from LDR Spine.

 

9. Integra Titan Modular Total Shoulder System Fin-Lock Glenoid from Ascension Orthopedics.

 

10. OsteoMed ExtremiLOCK Wrist Plating System from Osteomed.

 

11. PCT System from Centinel Spine.

 

12. Zero-P Natural Plate from Synthes.

 

13. Remedy Shoulder Spacer from Osteoremedies.

 

14. Twin Peaks Lumbar Interbody Fusion System from SpineWay.

 

15. Precice Trauma Nail System from Ellipse Technologies.

 

16. Rectangular Corpectomy Cage from Amendia.

 

17. FastFrame External Fixation System – Distal Radius from Zimmer.

 

18. TOMCAT Cervical Spinal System from Choice Spine.

 

19. Aero-C Cervical Cage System from Stryker Spine.

 

20. AXI+LINE Proximal Bunion Correction System from Nextremity Solutions.

 

21. XIA 4.5 Spinal Fixation System, Power Adaptor Instrument Accessory from Stryker.

 

22. AccuLIF TL and PL Cage from Stryker.

 

23. AOS Small Fragment Plating System from Advanced Orthopaedic Solutions.

 

24. FastFrame External Fixation System-Ankle Spanning from Zimmer.

 

25. NuVasive Foundation-LL System from NuVasive.

 

26. Arsenal Spinal Fixation System from Alphatec Spine.

 

27. ORTHOLOC 3Di Foot Plating Reconstruction System from Wright Medical Technology.

 

28. Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System from Xenco.

 

29. Endoskeleton TCS System from Titan Spine.

 

30. Klassic Knee System from Total Joint Orthopedics.

 

31. SpeedLock Knotless Fixation System from ArthroCare.

 

32. Apex Revision Knee System from OmniLife Science.

 

33. CD Horizon Spinal System from Medtronic Sofamor Danek.

 

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

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