16 spine devices receive FDA 510(k) clearance in August

Spinal Tech

The FDA approved 16 spine devices in August.

1. Nadia SI Fusion System from Ilion Medical.
2. Orion Spinal System from Orion Biotech.
3. Mondrian Lumbar Interbody Fusion Cage System from CTL Medical Corporation.
4. GS Medical AnyPlus PEEK Cage System from GS Medical.
5. Modulif-A Anterior Lumbar Interbody Fusion System from Spinal Stability.
6. K2M Navigation Instruments from Stryker.
7. Aurora Anterior Lumbar Plate System from Prism Surgical Design.
8. Adaptix Interbody System with Titan nanoLOCK Surface Technology from Medtronic Sofamor Danek.
9. CD Horizon Fenestrated Screw Set, System, Kyphon HV-R Bone Cement from Medtronic.
10. Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer from Life Spine.
11. Medina Anterior Cervical Plate System from Alliance Partners.
12. Monterey AL Interbody System from Stryker.
13. CoFix System from Paradigm Spine.
14. Confidence Spinal Cement System from DePuy Spine.
15. CarboClear Pedicle Screw System, CarboClear II Pedicle Screw System from CarboFix Orthopedics.
16. Cervical Plate System from Eminent Spine.

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