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

Spinal Tech

The Food and Drug Administration granted 510(k) clearance in December 2014.

1. Crystal, Mosaic, Vertu from Spinal Elements.

 

2. Juliet LL from Spineart.

 

3. PGS 5.5 MM Cannulated Pedicle Screw from Pinnacle Spine Group.

 

4. Herniatome Percutaneous Discectomy Device from Gallini Medical Devices.

 

5. Zevo Anterior Cervical Plate System from Medtronic Sofamor Danek.

 

6. AcrossSpine Pedicle Screw System from ArthroDif.

 

7. Ibis Pedicle Screw System from Ortho Development.

 

8. Bioceptive Suction Cervical Retractor from Bioceptive.

 

9. Valeo C Spacer System, Valeo II C IBF Device from Amedica.

 

10. Interspinous Plate System from Precision Spine.

 

11. SeaSpine Spacer System from SeaSpine.

 

12. Caspian OCT/MESA Mini/DENALI Mini Spinal System from K2M.

 

13. CD Horizon Spinal System says Medtronic Sofamor Danek.

 

14. MAS PLIF Fixation System from NuVasive.

 

15. Reform Pedicle Screw System from Precision Spine.

 

16. Threshold Pedicular Fixation System from Spineology.

 

17. InFill Graft Delivery System from Pinnacle Spine Group.

 

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