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

Spinal Tech

The FDA granted 17 spine-related device clearances in October.

1. Rampart D. Lumbar Interbody Fusion Device from Spineology.

2. XCage Interbody Fusion System from Ouroboros Medical.


3. Xenco Medical Cervical Interbody System from Xenco Medical.

4. MAGEC Spinal Bracing and Distraction System from NuVasive.

5. LumFix Spinal Fixation System from CG BIO.


6. PLEX Elite 9000 SS-OCT from Carl Zeiss Meditec.


7. Cavux Cervical Cage from Providence Medical Technology.


8. Overwatch Sypine System from Amendia.

9. Neuromonitoring kit from SI-BONE.

10. G-scan Brio, S-scan from Esaote.

11. M.U.S.T. Pedicle Screw System from Medacta.

12. NuVasive CoRoent Small Ti-C System from NuVasive.

13. FortiBridge Anterior Cervical Plate System from Nanovis Spine.


14. Firefly Pedicle Screw Navigation Guide from Mighty Oak Medical.


15. Pyrenees Cervical Plate System from K2M.

16. SeaSpine Spacer System-Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene from SeaSpine Orthopedics.

17. Libra Pedicle Screw System from Spinal Balance.


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