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

Spinal Tech

The Food and Drug Administration cleared 25 spine devices in June.

1. Captiva Spine SmartLOX Cervical Plate System from Captiva Spine.

 

2. Reliance Cervical IBF System from Reliance Medical Systems.

 

3. Elevate Spinal System from Medtronic Sofamor Danek USA.

 

4. Avenue T TLIF Cage from LDR Spine USA.

 

5. Mini Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360 Spinal Fixation System, Title 2 Polyaxial Spinal System from Zimmer Spine.

 

6. Iliac Pedicle Screw System and Zenius Pedicle Screw System from Medyssey USA.

 

7. STALIF C; STALIF C-Ti from Centinel Spine.

 

8. Divergence-L Anterior/Oblique Lumbar Fusion System from Medtronic Sofamor Danek USA.

 

9. Dymaxeon Spine System from Back 2 Basics Direct.

 

10. Navigated Disc Prep Instruments and Capstone Trials from Medtronic Sofamor Danek USA.

 

11. NuVasive CoRoent Small Interbody System from NuVasive.

 

12. Px PEEK IBF System form Innovasis.

 

13. Freedom Spinal Cord Stimulator System from Stimwave Technologies.

 

14. Ellipse and Protex CT Occipito-Cervico-Thoracic Spinal Systems from Globus Medical.

 

15. Anax OCT Spinal System from U&I Corporation.

 

16. Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti from Centinel Spine.

 

17. uNion Cervical Plate System from ulrich medical USA.

 

18. Sure Lok Mini Posterior Cerivcal/Upper Thoracic System from Precision Spine.

 

19. NuVasive CoRoent Thoracolumbar Implants from NuVasive.

 

20. Virage OCT Spinal Fixation System from Zimmer Spine.

 

21. CapLOX II/Tower LOX Pedicle Screw System from Captiva Spine.

 

22. ALIF Interfixated System from NuVasive.

 

23. Mercury Spinal System from Spinal Elements.

 

24. Lineum OCT Spine System from Biomet Spine.

 

25. Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade from Stryker.

 

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