22 spine devices receive FDA 510(k) clearance in April 2018

Spinal Tech

The FDA cleared 22 spine-related devices in April.


1. Reform POCT System from Precision Spine.

2. Half Dome Posterior Lumbar Interbody System from Astura Medical.

3. Mercury Spinal System from Spinal Elements.

4. Unity Sacroiliac Joint Fixation System from Huvexel.

5. Enza-A Titanium ALIF from Camber Spine Technologies.

6. MySpine Pedicle Screw Placement Guides from Medacta International.

7. SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device from SeaSpine.

8. UNiD Patient Specific 3D printed cage from Medicrea International.

9. Axis Anterior Cervical Plate System from Axis Orthopaedics.

10. Genesys Spine Binary Lumbar Plate System from Genesys Spine.

11. Mediant Anterior Cervical Plating System from Intelligent Implant Systems.

12. Rampart One Lumbar Interbody Fusion Device from Spineology.

13. Fibergraft BG Matrix Bone Graft Substitute from Prosidyan.

14. Cure Lumbar Plate System from Meditech Spine.

15. Creo Stabilization System from Globus Medical.

16. Axis 5.5 Lumbar pedicle Screw System from Axis Orthopaedics.

17. Mazor X from Mazor Robotics.

18. Patriot Spinal Fixation System from Valorus Spine.

19. K2M Patient Specific Rods from K2M.

20. Focus Pedicle Screw System from Nvision Biomedical Technologies.

21. Precice Stryde System from NuVasive Specialized Orthopedics.

22. Vertex Reconstruction System from Medtronic Sofamor Danek.


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