27 spine devices receive FDA 510(k) clearance in January

Spinal Tech

The Food and Drug Administration cleared 27 and spine-devices in January.

1. Spinous Process Fusion Plate from Spinal Simplicity.

 

2. MaxiMIS Spinal Fixation System from Valorem Surgical.

 

3. Firebird Spinal Fixation System from Orthofix.

 

4. Impix ALIF from Medicrea International.

 

5. New Era Orthopaedics Polyscrew Pedicle Screw System from New Era Orthopaedics.

 

6. Pass LP Spinal System from Medicrea International.

 

7. SImmetry Sacroiliac Joint Fusion System from Zyga Technology.

 

8. Divergence Anterior Cervical Fusion System from Medtronic.

 

9. Leva Spacer System from Spine Wave.

 

10. Construx Mini PEEK; Spacer System, TI Spacer System, Cervical and Standalone System from Orthofix.

 

11. Aviator Anterior Cervical Plate System from Stryker.

 

12. Everest Spinal System from K2M.

 

13. CB PROT II Posterior Spinal System from Chin Bone Technique.

 

14. EOS System from EOS Imaging.

 

15. Synapse Occipital-Cervical-Thoracic System from Synthes.

 

16. Lumenis M22 System from Lumenis.

 

17. Revolution Spinal Fixation System from Intelligent Implant Systems.

 

18. Endoskeleton TCS System from Titan Spine.

 

19. Ideal pedicle screw spinal system from Jiangsu Ideal Medical Science.

 

20. Proficient Facet Screw Spine System from Spine Wave.

 

21. NuVasive ALIF Buttress Plate System from NuVasive.

 

22. Arsenal Spinal Fixation System from Alphatec Spine.

 

23. Cannulated PediGuard Needle from SpineGuard.

 

24. AVS AL and Align PEEK Spacers from Stryker.

 

25. Range/Denali/Mesa Spinal System from K2M.

 

26. Verta Corpectomy Cage from Camber Spine.

 

27. CREO Stabilization System from Globus Medical.

 

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