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

Laura Dyrda -   Print  |

The FDA cleared 19 spine devices in October.


1. Republic Spine Restore Intervertebral Body Fusion System from Republic Spine.

2. SPIRA Open Matrix ALIF and LLIF from Camber Spine Technologies.

3. 4 CIS PEEK PLIF Cage from Solco Biomedical.

4. AccelFix Lumbar Interbody Fusion Cage System from L&K Biomed.

5. Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set from Medtronic Sofamor Danek.

6. CrossOver Cross Connectors, DePuy Pulse Thoracolumbar Screw System from Medos International.

7. Hedron Cervical Spacers from Globus Medical.

8. Precice System from NuVasive.

9. Ti3Z Cervical Interbody System from Zavation Medical Products.

10. Hedron Lumbar Spacers from Globus Medical.

11. NuVasive ACP System from NuVasive.

12. Ali Interbody Fusion System from Raed M. Ali, MD.

13. Mercury Spinal System, Overwatch Spinal System from Spinal Elements.

14. Genesys Spine Sacroiliac Joint Fusion System from Genesys Spine.

15. TranS1 Interbody Fusion System from TranS1.

16. Hinged Laminoplasty System from Life Spine.

17. Cartiva SCI instrumentation set from Cartiva.

18. Innovasis Gibralt Spine System from Inovasis.

19. NuVasive NuvaLine from NuVasive.

More articles on spine surgery:
Judge declines to bar former NuVasive employee from taking clients to Alphatec Spine
Medtronic reports $7.7B in Q2 revenue & more: 6 device company notes
Orthofix's M6-C cervical disc in 2019: 7 key developments

© Copyright ASC COMMUNICATIONS 2020. Interested in LINKING to or REPRINTING this content? View our policies here.

Featured Webinars

Featured Whitepapers