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

Spinal Tech

The Food and Drug Administration granted 22 spine device clearances in April.

1. Interbody Cage from Eisertech.

 

2. Reliance Interspinous Plate System from Reliance Medical Systems.

 

3. Solstice OCT System from Life Spine.

 

4. Zavation Posterior LEIF from Zavation.

 

5. G-scan Brio from Esaote.

 

6. Reliance Posterior Cervical-Thoracic System from Reliance Medical Systems.

 

7. CD Horizon Spinal System, IPC Powerease System from Medtronic Sofamor Danek.

 

8. PLIF STS, TLIF STS, OLIF STS from 4Web.

 

9. LnK Cervical Interbody Fusion Cage System from L&K Biomed.

 

10. Venus Spinal Fixation System from L&K Biomed.

 

11. NuVasive CCX-L Interbody System from NuVasive.

 

12. NuVasive Reline System from NuVasive.

 

13. FortiBridge Anterior Cervical Plate System from Nanovis Spine.

 

14. Implanet Spine System from Implanet.

 

15. SpineFrontier SIJ Fuse Sacroiliac Joint Fusion Device System from SpineFrontier.

 

16. InFill Interbody Fusion Devices from Pinnacle Spine.

 

17. Facet-Link Stabilization Platform from Facet-Link.

 

18. Solstice OCT System from Life Spine.

 

19. Streamline OCT System from Pioneer Surgical Technology.

 

20. Republic Spine Dark Star Spinal System from Republic Spine.

 

21. Kyphon HV-R Bone Cement from Medtronic Sofamor Danek.

 

22. Santis Pedicle Screw System from Lanterna Medical Technologies.

 

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Webinars

Featured Whitepapers