18 spine devices receive FDA 510(k) clearance in August

Spinal Tech

The Food and Drug Administration cleared 18 spine-related devices in August.

1. NuVasive Sterilization Trays from NuVasive.

 

2. Cascadia Interbody System from K2M.

 

3. Synfix Evolution Secured Spacer System from Synthes.

 

4. Vitality Spinal Fixation System from Zimmer Spine.

 

5. Aesculap T-Space PEEK and XP Spinal System from Aesculap Implant Systems.

 

6. Solitaire-C Cervical Spacer System, C-thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System form Biomet Spine.

 

7. Capstone Spinal System, Clydesdale Spinal System from Medtronic Sofamor Danek.

 

8. LnK Lumbar Interbody Fusion Cage System from L&K Biomed.

 

9. MasterGraft Contain from Medtronic Sofamor Danek.

 

10. NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, Expandable XLIF System from NuVasive.

 

11. Reform Pedicle Screw System form Precision Spine.

 

12. Angel Pedicle Screw Spinal System from Jiangsu Angel Medical Instrument.

 

13. Jazz System from Implanet.

 

14. HA Minuteman G3 MIS Fusion Plate from Spinal Simplicity.

 

15. SteriSpine LC Cage from Safe Orthopaedics.

 

16. SImmetry Sacroiliac Joint Fusion System from SImmetry.

 

17. Precision Spine Interspinous Plate System from Precision Spine.

 

18. Sniper Spine System from SpineWave.

 

 

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