19 spine devices receive FDA 510(k) clearance in December

The FDA cleared 19 spine devices in December.

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1. C-Zero Pedicle Screw System, Freedom Pedicle Screw System from Signature Orthopaedics.

2. Met One Czar Anterior Cervical Plate System from Met One Technologies.

3. TruMatch Graft Cage – Long Bone from Synthes USA.

4. Revel Spacers from Globus Medical.

5. DePuy Synthes T-PAL Spacer System from DePuy Synthes Spine.

6. Patriot Lumbar Spacers, Sustain Spacers from Globus Medical.

7. Curiteva Lumbar Interbody Fusion System from Curiteva.

8. Life Spine Resolute Threaded Cage System from Life Spine.

9. Renovis Tesera C/Tesera SC Anterior Cervical Fusion System from Renovis.

10. Leucadia Autolok Pedicle Screw System from ClearView Orthopedic Development.

11. Pyrenees Cervical Plate System, Blue Ridge Cervical Plate System, Zoark Cervical Plate System, Cayman Thoracolumbar and Buttress Plate Systems from K2M.

12. Lucent from Spinal Elements.

13. Salvo Spine System from Spine Wave.

14. Aurora Screw System from MiRus.

15. Mega Plus Spine System from BK Meditech.

16. IlluminOss Photodynamic Bone Stabilization System from IlluminOss Medical.

17. OpenLoc-L Spinal Fixation System from L&K Biomed.

18. CoreLink F3D Lateral System from CoreLink.

19. Anax OCT Spinal System from U&I Corporation.

More articles on orthopedic devices:
Medtronic, Stryker, Globus Medical & more: 13 device company notes
Spinal fusion devices make up 58% of products market—10 key players
Globus Medical projects 2018 sales at $712.5M: 5 notes

 

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