25 spine devices receive FDA 510(k) clearance in April

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

The Food and Drug Administration granted 25 spine-related device clearances in April.

1. Sustain TPS Spacers, Patriot TPS Spacers, Caliber TPS Spacer, Coalition TPS Spacers, Independence TPS Spacer, Fortify-R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer from Globus Medical.

2. Diplomat Spinal System from Signus Medizintechnik.

3. icotec Pedicle System from Icotec AG.

4. KLS Martin LSS Plating System from KLS Martin.

5. Genesys Spine Apache Interbody Fusion System from Genesys Spine.

6. Syzyqy Stabilization System from Amendia.

7. Leva Spacer System from Spine Wave.

8. Zavation Spinal System from Zavation.

9. PASS LP Spinal System from Medicrea.

10. NuVasive CoRoent Thoracolumbar System from NuVasive.

11. Olympic Posterior Spinal Fixation System from Astura Medical.

12. Inertia Pedicle Screw and Deformity Correxxion System from Nexxt Spine.

13. Pyrenees Cervical Plate System from K2M.

14. Alphatec Navigation Instruments from Alphatec Spine.

15. NuVasive Interfixated Interbody System from NuVasive.

16. LUMIS Cannulated Pedicle Screw Fixation System from U.L.I.S. Pedicle Screw Fixation System.

17. Cascadia Interbody System from K2M.

18. Revolution Spinal Fixation System from Intelligent Implant Systems.

19. Precice Intramedullary Limb Lengthening System from Ellipse Technologies.

20. spineEOS from OneFit Medical.

21. Opticage Expandable Interbody Fusion Device from Interventional Spine.

22. White Pearl Preferred Angle Anterior Cervical Plate from Osseus Fusion Systems.

23. G3 Active Plate Small Fragment System from Genesis Fracture Care.

24. PASS OCT Spinal System from Medicrea.

25. Denali Filter System – Femoral Delivery Kit, Denali Filter System – Jugular/Subclavian Delivery Kit from C.R. Bard.


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