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

Spinal Tech

The FDA cleared 22 spine-related devices in October 2018.

1. Cellent Spinal Systems from Jiangsu Trauhui Medical Instrument.

2. Anthem Fracture System from Globus Medical.

3. Orthros Posterior Stabilization System; Orthros MIS Posterior Stabilization System from Camber Spine.

4. SpineEx Sagittae Lateral Lumbar Interbody Fusion Devices from SpineEx.

5. Cios Spin from Siemens Medical Solutions USA.

6. Cios Alpha from Siemens Medical Systems.

7. Spine Wave Navigated Instruments from Spine Wave.

8. Everest Spinal System, Range (Mesa and Denali) Spinal System, Caspian OCT (Mesa Mini and Denali Mini) Spinal System, Yukon OCT Spinal System from K2M.

9. Stable-C Interbody System from Nexus Spine.

10. Life Spine Laminoplasty System from Life Spine.

11. Scarlet AL-T from Spineart.

12. NuVasive Cohere Thoracolumbar Interbody System from NuVasive.

13. Outlet Sacroiliac Joint Fusion System from SIJ Surgical.

14. Symphony OCT System from Medos International SARL.

15. Prase MIS Spinal System from GBS Commonwealth.

16. Monet Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate from CTL Medical Corp.

17. Olympic Posterior Spinal Fixation System from Astura Medical.

18. PASS LP Spinal System from Medicrea International.

19. FUSE Pedicle Screw System from Black Box Medical.

20. Duo Lumbar Interbody Fusion Device from Spineology.

21. Powerease System from Medtronic Sofamor Danek.

22. EIT Cellular Titanium Lumbar Cage LLIF from EIT Emerging Implant Technologies.

 

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

 

Featured Webinars

Featured Whitepapers