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

Written by Laura Dyrda | March 11, 2019 | Print  |

The FDA granted 21 spine-related device clearances last month.

1. Altus Spine Interbody Fusion System from Altus Partners.

2. Atlantis Anterior Cervical Plate, Divergence Anterior Cervical Fusion System from Medtronic Sofamor Danek.

3. Divergence Anterior Cervical Fusion System from Medtronic Sofamor Danek.

4. Premier Anterior Cervical Plate from Medtronic Sofamor Danek.

5. Venture Anterior Cervical Plate from Medtronic Sofamor Danek.

6. Zephir Anterior Cervical Plate System from Medtronic Sofamor Danek.

7. Zevo Anterior Cervical Plate System from Medtronic Sofamor Danek.

8. NuVasive Reline System from NuVasive.

9. Reliance Lumbar IBF System from Reliance Medical Systems.

10. SMG Anterior Cervical Plate System from Sapphire Medical Group.

11. Spectra Optia Apheresis System from Terumo BCT.

12. Shoreline Cervical Interbody RT System from SeaSpine Orthopedics.

13. SI-LOK Sacroiliac Joint Fixation System, Navigation instruments, Excelsius GPS Instruments from Globus Medical.

14. Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker from Stryker.

15. Athena II Cervical Plate System from Medyssey USA.

16. Endoskeleton TA Interbody Fusion Device, Endoskeleton TA Vertebral Body Replacement Device from Titan Spine.

17. Choice Spine Hawkeye Vertebral Body Replacement from ChoiceSpine.

18. Omnia Medical Rotary PLIF System from Omnia Medical.

19. Velofix Interbody Fusion System from U&I Corp.

20. Perla Posterior Cervico-Thoracic Fixation System from Spineart.

21. Pedimax II Pedicular Screw Spinal System from Gm Dos Reis Industria E Comerico.

More articles on orthopedic devices:
Orthofix earns FDA premarket approval for M6-C artificial disc
38 orthopedic devices receive FDA 510(k) clearance in February
Alphatec reports 9.9% drop in 2018 revenue, secures $30M in additional financing

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