22 spine devices receive FDA 510(k) clearance in May 2018

Written by Laura Dyrda | June 20, 2018 | Print  |

The FDA cleared 22 spine-related devices in May.


1. Icotec Interbody Cage System from icotec ag.

2. A-CIFT SoloFuse from SpineFrontier.

3. SeaSpine Navigation System from SeaSpine Orthopedics.

4. SpineKure Kyphoplasty System from Hanchang.

5. Stalif C FLX from Centinel Spine.

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

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

8. NuVasive XLX Interbody System from NuVasive.

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

10. Hexanium TLIF from SpineVision.

11. Harrier-SA Lumbar Interbody System from ChoiceSpine.

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

13. Arthrex FastThread Interference Screw from Arthrex.

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

15. Reliance Lumbar IBF System from Reliance Medical Systems.

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

17. Spineology Navigation Instruments from Spineology.

18. Aerial Interspinous Fixation from Globus Medical.

19. DTRAX Spinal System from Providence Medical Technology.

20. EVOL Spinal Interbody System from Cutting Edge Spine.

21. Navigated Infinity Instruments from Medtronic Sofamor Danek USA.

22. Everest Spinal System from K2M.

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