25 Spine Devices Receive FDA 510(k) Clearance in April

Spinal Tech

The Food and Drug Administration granted 25 spine-related 510(k) clearances in April.

1. Innesis PEEK Cervical Cage from BK Meditech.


2. Coroent Small Interbody System from NuVasive.


3. Aleutian IBF System from K2M.


4. Medinaut Kyphoplasty System from Imedicom.


5. Abacus TM Spacer System from Spine Wave.


6. Baxano Surgical MIS Spinal System from Baxano Surgical.


7. Orthros Posterior Stabilization System from Camber Spine.


8. Streamline TL Spinal Fixation System from Pioneer Surgical Technology.


9. Spineworks Anterior Lumbar Device from Spineworks.


10. Discoscopes, Cervical Endoscopes from RZ Medizintechnik GMBH.


11. Cervical Stand Alone System from Orthofix.


12. Picasso II MIS Spinal System from Accel Spine.


13. Cogent Med-LIF form Cogent Spine.


14. Intess Cervical Cage System from Kalitec Direct.


15. AIS ModuLIF VBR System from Aesculap Implant System.


16. Proposed Optimus from Custom Spine.


17. Zip MIS Interspinous Fusion System from Aurora Spine.


18. AnyPlus; ALIF PEEK Cages, PLIF PEEK Cages, T-PLIF PEEK Cages from GS Medical.


19. Juliet OL from Spineart.


20. Fortress Pedicle Screw System from Spineology.


21. Polaris Spinal System-Translation Screw from EBI.


22. Octane Elevate Spinal Implant System from Exactech.


23. Reliance Anterior Cervical Plate from Reliance Medical Systems.


24. Anatomic PEEK PTC Cervical Fusion System from Medtronic Sofamor Danek.


25. General Spinal System from Tianjin Walkman Biomaterial.


More Articles on Spine Clearances:
20 Spine Devices Receive FDA 510(k) Clearance in March
11 Spine Devices Receive FDA 510(k) Clearance in February
16 Spine Devices Receive FDA 510(k) Clearance in January

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