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13 spine devices receive FDA 510(k) clearances in November Featured

By  Laura Dyrda | Friday, 11 December 2015 00:00
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The Food and Drug Administration cleared 13 spine devices in November.

1. Waston General Spinal System from Changzhou Watson Medical Appliance.

 

2. AVAflex Vertebral Balloon System from CareFusion.

 

3. Libra Pedicle Screw System from Spinal Balance.

 

4. Concorde Bullet Lumbar Interbody System from Medos International.

 

5. Integrity Spine Lumbar Interbody Fusion System from Integrity Spine Lumbar Interbody.

 

6. Polaris Spinal System from Biomet Spine.

 

7. Renaissance X System from Mazor Robotics.

 

8. CD Horizon Spinal System from Medtronic Sofamor Danek USA.

 

9. InFill Interbody Fusion Device from Pinnacle Spine Group.

 

10. PIVOX Oblique Lateral Spinal System from Medtronic Sofamor Danek.

 

11. Cam Lock Plating System from Life Spine.

 

12. Atlantis Anterior Cervical Plate System from Medtronic Sofamor Danek.

 

13. Range/Denali/Mesa Spinal System from K2M.

 

More articles on spine devices:
18 spine devices receive FDA 510(k) clearance in October
25 spine devices receive FDA 510(k) clearances in September
18 spine devices receive FDA 510(k) clearance in August

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