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

Spinal Tech

The Food and Drug Administration granted 15 spine-related device clearances in August.

1. Kiva VCF Treatment System from Benvenue Medical.

 

2. InFront Lumbar Interbody Fusion System from InFront.

 

3. Confirm Bioactive from Globus Medical.

 

4. Exactech Cervical Spacer System from Exactech.

 

5. CD Horizon Spinal System from Medtronic Sofamor Danek.

 

6. PerFuse Percutaneous Decompression System from Biomet.

 

7. Romeo PAD Posterior Axial Device from Spineart.

 

8. Isola and Expedium Growing Spine Systems from Medos SARL.

 

9. VertiForm Posterior Fixation System from Next OrthoSurgical.

 

10. Z-Link Cervical from Zavation.

 

11. Mercury Spinal System from Spinal Elements.

 

12. aap Loqtec Cervical Plates from aap Implantate.

 

13. Lateral VBR System from NuVasive.

 

14. MUST Pedicle Screw System from Medacta.

 

15. Thunderbolt and Lancer Pedicle Screw Systems from Choice Spine.

 

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