28 spine devices receive FDA 510(k) clearance in July

Spinal Tech

The FDA cleared 28 spine-related devices in July 2018.

 1. CarboClear Pedicle Screw System from CarboFix Orthopedics.

2. Jasper Spinal Fixation System from GBS Commonwealth.

3. PEEKplus Interbody Fusion Device from Vallum Corp.

4. Lumbar Interbody Fusion System from Advanced Research Medical.

5. Athena Cervical Plate System from Medyssey USA.

6. Ti 3z Interbody System from Zavation Medical Products.

7. Trend II Spinal Fixation System – STEP Series from Paonan.

8. Corelink Foundation 3D Anterior Lumbar System from Corelink.

9. DePuy Synthes Static Staples from Synthes USA Products.

10. Tyber Medical PT Interbody Spacer System from Tyber Medical.

11. Viking Lumbar Polyaxial Screw System from Presidio Surgical.

12. Normandy VBR System from Zavation Medical.

13. Vail ALIF Buttress Plate System from Evolution Spine.

14. Tritanium PL Cage from Stryker Spine.

15. Rubicon Lumbar Interbody Fusion System from Rubicon Spine.

16. CxHA PEEK Cervical IBF System from Innovasis.

17. Olympic Posterior Spinal Fixation System from Astura Medical.

18. Zavation Cervical Plate System from Zavation Medical.

19. Zavation IBF System from Zavation Medical Products.

20. Curiteva Cervical Interbody Fusion System from Curiteva.

21. Altus Spine Pedicle Screw System from Altus Partners.

22. Astra-OCT Spine System from SpineCraft.

23. Firefly Pedicle Screw Navigation Guide from Mighty Oak Medical.

24. Proficient Posterior Cervical Spine System from Spine Wave.

25. ATEC ALIF Spacer System from Alphatec Spine.

26. Republic Spine Dark Star Spinal System from Republic Spine.

27. Stowe Pedicle Screw System from Black Box Medical.

28. PathLoc-SI Joint Fusion System from L&K Biomed.

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