35 orthopedic, spine devices receive FDA 510(k) clearance in May 2018

Spinal Tech

The Food and Drug Administration cleared 35 orthopedic- and spine-focused devices in May 2018.


1. Trident Extemity Fixation System from Trident Orthopedics.

2. Icotec Interbody Cage System from icotec ag.

3. A-CIFT SoloFuse from SpineFrontier.

4. SeaSpine Navigation System from SeaSpine Orthopedics.

5. Zimmer personal Personalized Knee System from Zimmer.

6. OrthoPediatrics PediNail Intramedullary Platform from OrthoPediatrics.

7. SpineKure Kyphoplasty System from Hanchang.

8. Stalif C FLX from Centinel Spine.

9. Patriot Colonial Spacer, Sustain Spacer from Globus Medical.

10. InTice-C Porous Ti Cervical Interbody System from X-Spine Systems.

11. NuVasive XLX Interbody System from NuVasive.

12. Legend Acetabular Liners from Ortho Development Corp.

13. STYLO Interbody Device from Legend Spine Technologies.

14. SAGICO OSI Spinal System by Osimplant from Spinal Analytics & Geometrical Implants.

15. Additive Orthopaedics Patient Specific 3D Printed Bone Segments from Additive Orthopaedics.

16. Evolution Knee Systems – MR Labeling, Evolution Biofoam Tibial System from MicroPort Orthopedics.

17. Hexanium TLIF from SpineVision.

18. Harrier-SA Lumbar Interbody System from ChoiceSpine.

19. Guided Growth Plate System Plus from Orthofix.

20. Pro-Link Ti Stand-alone Cervical Spacer System from Life Spine.

21. Arthrex FastThread Interference Screw from Arthrex.

22. SeaSpine Daytona Small Suture Spinal System from SeaSpine Orthopedics.

23. Reliance Lumbar IBF System from Reliance Medical Systems.

24. Kyphon HV-R Bone Cement from Medtronic Sofamor Danek.

25. Spineology Navigation Instruments from Spineology.

26. Omni Foot Plating System from Extremity Medical.

27. Aerial Interspinous Fixation from Globus Medical.

28. DTRAX Spinal System from Providence Medical Technology.

29. EVOL Spinal Interbody System from Cutting Edge Spine.

30. ConforMIS iTotal Cruciate Retaining Knee Replacement System from ConforMIS.

31. Klassic HD Hip System from Total Joint Orthopedics.

32. Diamond Orthopedic Bone Fixation Screws and Pins from Diamond Orthopedic.

33. AlignX Ankle Fusion System from Extremity Medical.

34. Navigated Infinity Instruments from Medtronic Sofamor Danek USA.

35. Everest Spinal System from K2M.


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