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

Spinal Tech

The FDA cleared 26 spine-related devices in January 2016.

1. Amendia Interbody Fusion Devices from Amendia.

2. VerteLP Interbody Fusion Device from VGI.

 

3. ROSA Spine from MEDTECH.


4. Ellipse Supplemental Instrument Trays from Ellipse Technologies.

 

5. AVS AL and AVS Align PEEK, AVS PL and AVS UniLIF PEEK Spacers from Stryker.

 

6. Coalition Spacers from Globus Medical.

7. FacetBRIDGE System from LDR Spine.

8. Medtronic Transportation/Sterilization Cassettes from Medtronic Sofamor Danek.

9. FORZA PTC Spacer System from Orthofix.

10. Half Dome Posterior Lumbar Interbody System from Astura Medical.

11. Kyphon HV-R Fenestrated Screw Cement, CD Horizon Fenestrated Screw Set from Medtronic Sofamor Danek USA.

12. Spine Wave Gen II Expandable Interbody System from Spine Wave.

13. Unison-C Anterior Cervical Fixation System from Pioneer Surgical Technology.

14. K2M Fenestrated Tap System from K2M.

 

15. NuVasiveNVM5 System from NuVasive.

 

16. Amendia Stand-Alone Cervical System from Amendia.

17. aap LOQTEQ VA Radius Set 2.5 from aap Implantate.

18. PASS OCT Patient Specific Rods from MEDICREA.

 

19. VuePoint OCT System from NuVasive.

 

20. Cornerstone PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK from PREVAIL Cervical Interbody Device.

 

21. Perla Posterior Cervico-Thoracic Fixation system from Spineart.

 

22. Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System from Orthofix.

23. Senecka II Polyscrew Pedicle Fixation System from Senecka Spine.

 

24. M.U.S.T. Pedicle Screw System from MEDACTA.

 

25. Biomet Spine Fusion System from Biomet Spine.

26. Release Laminoplasty Fixation System from Pioneer Surgical Technology.

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