21 spine devices receive FDA 510(k) clearance in January

Spinal Tech

The FDA approved 21 spine-related devices in January.


1. II-Type Intervertebral Spacer from Paonan Biotech.

2. NEST Interbody System form Paonan Biotech.

3. VariLift-LX Interbody Fusion system, VariLift-C Interbody Fusion System from Wenzel Spine.

4. Avenue P Cage System from Zimmer Biomet Spine.

5. Reliance Lumbar IBF System from Reliance Medical Systems.

6. Pinehurst Anterior Cervical Plate System from Signature Orthopaedics.

7. FlareHawk Interbody Fusion System from Integrity Implants.

8. TiWave-L Porous Titanium Lumbar Cage from Kalitec Medical.

9. Tyber Medical PT Interbody Spacer from Tyber Medical.

10. Cervical Spacer from Additive Implants.

11. Whistler Modular Pedicle Screw System from Evolution Spine.

12. 4CIS Pinehurst Anterior Cervical Plate System from Solco Biomedical.

13. OsteoCool RF Ablation System from Medtronic Sofamor Danek.

14. Choice Spine Navigation System from Choice Spine.

15. SI-Restore Sacroiliac Joint Fixation System from Biofusion.

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

17. Europa Pedicle Screw System from MiRus.

18. CervAlign Anterior Cervical Plate System from Pioneer Surgical Technology.

19. VLIFT-s Vertebral Body Replacement System from Stryker Spine.

20. Raven Lumbar Plate System from Choice Spine.

21. T2 Stratosphere Expandable Corpectomy System from Medtronic Sofamor Danek.

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