19 Spine Devices Receive FDA 510(k) Clearance in December

Spinal Tech

The Food and Drug Administration granted 19 spine-related device clearances in December.

1. Perimeter C Spinal System from Medtornic Sofamor Danek.

 

2. Anodyne Anterior Cervical Plate System from CoreLink.

 

3. CD Horizon Spinal System from Medtronic Sofamor Danek.

 

4. Staxx System from Spine Wave.

 

5. K7 Lumbar Spacers from K7.

 

6. Genesys Spine Apache IBFD Star Cervical System from Genesys Spine.

 

7. Clydesdale Spinal System from Medtronic Sofamor Danek.

 

8. Certex OCT Spinal Implant System from X-Spine Systems.

 

9. Genesys Spine Apache Lateral Lumbar Interbody Fusion System from Genesys Spine.

 

10. Mikron Spinal Fixation System from Mikron Makina Sanayi VE Ticaret.

 

11. DePuy Synthes Spine DENS Access System from Synthes USA Products.

 

12. Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation System from Stryker Spine.

 

13. ST360 Degrees Spinal Fixation System from Zimmer Spine.

 

14. Struxxure Anterior Cervical Plate and Screws from Nexxt Spine.

 

15. Affix Next Gen Spinous Process Plate System from NuVasive.

 

16. Capstone Spinal System from Medtronic Sofamor Danek.

 

17. InFix Anterior Lumbar Spine from Zimmer Spine.

 

18. Velox Anterior Cervical Plate System from SpineCraft.

 

19. Pioneer MaxFuse Vertebral Body Replacement Device from Pioneer Surgical Technology.

 

More Articles on Spine Devices:
19 Spine Devices Receive FDA 510(k) Clearance in November
17 Spine Devices Receive FDA 510(k) Clearance in October
18 Spine Devices Receive FDA 510(k) Clearance in September

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