The Food and Drug Administration granted 21 spine-related 510(k) clearance in July.
1. Choice Spine Lumbar Spacer System from Choice Spine.
2. Skyhawk Lateral Plate System from Orthofix.
3. Endoskeleton TL Interbody Fusion Device from Titan Spine.
4. Range/Mesa/Denali Spinal System from K2M.
5. FlxFit Intervertebral Body Fusion Device from Expanding Orthopedics.
6. IRIX-A Lumbar Integrated Fusion System from X-Spine Systems.
7. IFuse Implant System from SI-BONE.
8. Coroent XLIF System from NuVasive.
9. MLX-Medial Lateral Expandable Lumbar Interbody System from NuVasive.
10. Milestone Spinal System from Weigo Orthopaedic Device.
11. Coroent Small Interbody System from NuVasive.
12. Caspian OCT Spinal System from K2M.
13. AP Expandable XLIF System from NuVasive.
14. PLIF Lite and TLIF Lite from Sintea Plustek.
15. K2M Modular Hooks from K2M.
16. Velox Interbody Fusion System from U&I Corp.
17. Altera Spacer from Globus Medical.
18. C-Jaws Cervical Compressive Staple from Medicrea International.
19. Caspian Spinal System from K2M.
20. Divergence Mini-Plate Anterior Cervical Fusion System from Medtronic.
21. CD Horizon Spinal System from Medtronic Sofamor Danek.
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