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

Spinal Tech

The Food and Drug Administration cleared 34 orthopedic- and spine-related devices in November.

1. J-screw compression screw from Competitive Engineering.

 

2. Maxan Anterior Cervical Plate System from Biomet Spine.

 

3. Saiph Knee System from MatOrtho.

 

4. Opticage Expandable Interbody Fusion Device from Intervertebral Spine.

 

5. Pass LP Spinal System from Medicrea.

 

6. ToggleLoc and JuggerLoc Implant/Instruments/Kits from Biomet.

 

7. Zip MIS Interspinous Fusion System from Aurora Spine.

 

8. Arena-C TiFuse Cervical Intervertebral Body Fusion Device from SpineFrontier.

 

9. Aequalis Fx2 from Tornier SAS.

 

10. Journey II XR Knee from Smith & Nephew.

 

11. C2 Spinal Fixation System from SpineSmith.

 

12. Orthofix Ankle Hindfoot Nailing System from Orthofix.

 

13. CoRoent System from NuVasive.

 

14. NuVasive NVM5 System from NuVasive.

 

15. MAKOplasty Total Hip Application, RIO Standard System from MAKO Surgical.

 

16. Encore Humeral Shoulder Stem from Encore Medical.

 

17. Capri from K2M.

 

18. Luna Interbody System from Benvenue Medical.

 

19. Transom Anterior Cervical Plate from Neurostructures.

 

20. Aero-LL Lumbar Cage System from Stryker.

 

21. Glenoid Intelligent Reusable Instrument System from Custom Orthopaedic Solutions.

 

22. SMR 40MM Glenosphere from LimaCorporate.

 

23. iTotal Cruciate Retaining Knee Replacement System, iTotal Posterior from ConforMIS.

 

24. Expedium Verse Spine System from DePuy Spine.

 

25. LessRay with Tracking from SafeRay Spine.

 

26. AVS AS PEEK Spacer from Stryker.

 

27. KangLif Pedicle Screw Spinal System from Suzhou Kangli Orthopaedics Instruments.

 

28. CoRoent Small Interlock System from NuVasive.

 

29. Amedica Valeo II Interbody Fusion Device from Amedica.

 

30. Anatomical Shoulder System/Domelock System/Fracture System from Zimmer.

 

31. Titan Modular Total Shoulder System from Ascension Orthopedics.

 

32. Restoration Anatomic Shell from Stryker Orthopaedics.

 

33. Reline Spine from NuVasive.

 

34. Smith & Nephew Spatialframe.com V5.0 Web-based software from Smith & Nephew.

 

35. Evolution MP Revision Femur, Evolution Femoral Augments from Microport Orthopedics.

 

36. PhaLinx Hammertoe System from Wright Medical Technology.

 

37. Vertecal Expandable Prosthetic Titanium Rib from DePuy Synthes Spine.

 

38. Biomet Headless Compression and Twist-off Screws from Biomet Manufacturing.

 

39. Zimmer Plates and Screws, Forte Screws from Zimmer.

 

40. Universe Rivers Shoulder Prosthesis System from Arthrex.

 

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

 

42. Arthrex iBalance Patella Implant, Dome from Arthrex.

 

43. Zimmer Plates and Screws – Non Sterile Plate Line Extensions, Sterile/Non Sterile ZPS/Screws and Washers from Zimmer.

 

44. Vega Knee System from Aesculap Implant Systems.

 

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