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

Spinal Tech

The FDA cleared 18 spine-related devices in August 2018.

1. Firebird Spinal Fixation System from Orthofix.

2. Geister retractor for neuro- and spine surgery from Geister Medizintechnik.

3. K2M Expandable Interbody System from K2M.

4. TirboLOX-L Lumbar IBFD from Captiva Spine.

5. Aptus CMC-I Fusion Plate System from Medartis.

6. SpineJack Expansion Kit from Vexim.

7. Genesys Spine AIS-C Cervical Stand-Alone System from Genesys Spine.

8. Aries Lumbar Interbodies from Osseus Fusion Systems.

9. NuVasive Brigade Lateral System from NuVasive.

10. Atec Cervical Spacer System from Alphatec Spine.

11. Accufuse Cervical System from Absolute Advantage Medical.

12. Tranquil Interbody System from Nexus Spine.

13. Cure Opel-C Plate System from Meditech Spine.

14. Curiteva Midline Anterior Cervical Plate System from Curiteva.

15. Kodiak Spinal Fixation System from Alphatec Spine.

16. Duo Lumbar Interbody Fusion Device from Spineology.

17. Zenius, Iliad and Kora Spinal Fixation Systems from Medyssey USA.

18. CD Horizon Spinal System from Medtronic Sofamor Danek.

 

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