The Food and Drug Administration has granted 19 spine-related device clearances in November.
1. Perimeter Interbody Fusion Device from Medtronic Sofamor Danek.
2. Pass LP Spinal System from Medicrea International.
3. Cayman MI Plate System from K2M.
4. Spectrum Spine Spinous Process Device from Spectrum Spine.
5. Integrity Spine Core System from Integrity Spine.
6. Universe Spinous Process Fixation Plate from Stryker Spine.
7. Integra Facet Fixation System from Seaspine.
8. Apex Spine System from Spinecraft.
9. Everest Spinal System from K2M.
10. Affix II Spinous Process Plate System from NuVasive.
11. SP-FIX Spinous Process Fixation Plate from Globus Medical.
12. Crescent Spinal System from Medtronic Sofamor Danek.
13. CD Horizon Spinal System from Medtronic Sofamor Danek.
14. Vault-C Intervertebral Body Dancing from Empirical Testing.
15. Pathfinder NXT Minimally Invasive Pedicel Screw System from Zimmer Spine.
16. Tiger Occipital Cervical-Thoracic Spinal Fixation System from CoreLink.
17. AIGIS RX N, Medium & Large, from TYRZ.
18. ESPIN System from NLT Spine.
19. Lessray from Saferay Spine.
More Articles on Spine Device Clearances:
17 Spine Devices Receive FDA 510(k) Clearance in October
18 Spine Devices Receive FDA 510(k) Clearance in September
20 Spine Devices Receive FDA 510(k) Clearance in August