38 orthopedic & spine devices receive FDA 510(k) clearance in June 2018

Spinal Tech

The FDA cleared 38 orthopedic and spine devices in June.


1. Trident Extremity Fixation System from Trident Orthopedics.

2. Icotec Interbody Cage System from icotec.

3. A-CIFT SoloFuse from SpineFrontier.

4. SeaSpine Navigation System from SeaSpine Orthopedics.

5. Zimmer Persona Personalized Knee System from Zimmer.

6. OrthoPediatrics PediNail Intramedullary Platform from OrthoPediatrics.

7. SpineKure Kyphoplasty System from Hanchang.

8. Kator Suture Anchor from Kator.

9. STALIF C FLX from Centinel Spine.

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

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

12. NuVasive XLX Interbody System from NuVasive.

13. Legend Acetabular Liners from Ortho Development.

14. Stylo Interbody Fusion Device from Legend Spine Technologies.

15. Healix Advance Knotless BR Anchor from Medos International.

16. Sagico OSI Spinal System by Osimplant from Spinal Analytics.

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

18. Evolution Knee Systems from MicroPort Orthopedics.

19. Hexanium TLIF from SpineVision.

20. Aevumed Phantom Suture Anchors from Aevumed.

21. Atec Universal Spacer System from Alphatec Spine.

22. Harrier-SA Lumbar Interbody System from ChoiceSpine.

23. Guided Growth Plate System Plus from Orthofix.

24. Pro-Link Ti Stand-Alone Cervical Spacer System from Life Spine.

25. Arthrex FastThread Interference Screw from Arthrex.

26. SeaSpine Daytona Small Stature Spinal System from SeaSpine Orthopedics.

27. Reliance Lumbar IBF System from Reliance Medical Systems.

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

29. Spineology Navigation Instruments from Spineology.

30. Omni Foot Plating System from Extremity Medical.

31. Aerial Interspinous Fixation from Globus Medical.

32. DTRAX Spinal System from Providence Medical Technology.

33. EVOL Spinal Interbody System from Cutting Edge Spine.

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

35. Klassic HD Hip System from Total Joint Orthopedics.

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

37. AlignX Ankle Fusion System from Extremity Medical.

38. Everest Spinal System from K2M.

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