20 Spine Devices Receive FDA 510(k) Clearance in June

Spinal Tech

The Food and Drug Administration granted 20 spine-related device clearances in June. 1. SpineVision Lumis Cannulated Polyaxial Pedicle Screw Fixation System from
SpineVision.

2. Capsure PS System from Spine Wave.

3. Honour Spacer System from Nexxt Spine.

4. Spineology PEEK Lumbar Interbody Fusion Devices from Spineology.

5. Synthes Scout Tack Fixation from Synthes Spine.

6. Expedium Spine System, Viper Spine System, Viper 2 System from DePuy Spine.

7. Revere 4.5 Stabilization System from Globe Medical.

8. Audit MicroLQ Spinal Fluid Control from AALTO Scientific.

9. Polaris Spinal System-Ballista Spinal Rods from Biomet Spine.

10. Medyssy LT Cage System from Medyssey.

11. OP Spine System from Orthopediatrics.

12. Blue Mountain Cervical Plate from QualGenix.

13. Xia 4.5 Spinal System from Stryker.

14. Enspire Discectomy System from Spine View.

15. LDR Spine SpineTune TL Spinal System form LDR Spine USA.

16. Unify Dynamic Anterior Cervical Plate System from Globe Medical.

17. Range Spinal System from K2M.

18. Vu aPOD Intervertebral Body Fusion Device from Theken Spine.

19. NuVasive Corent Titanium System from NuVasive.

20. Vertex Reconstruction System from Medtronic Sofamor Danek.

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