28 orthopedic & spine devices receive FDA 510(k) clearance in February

Spinal Tech

The Food and Drug Administration granted 28 orthopedic- and spine-related clearances in February.

1. Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs from K2 Medical.


2. Arthrex Short Suture Anchors from Arthrex.


3. Cogent Lateral Interbody System from Cogent Spine.


4. IRENE Locking Compression Plate System from Tianjin Zhengtan Medical Instruments.


5. Anterior Cervical Plate System from Osteomed Implantes.


6. The Entasis Dual-Lead Sacroiliac Implant from CoreLink.


7. Yahua Spinal System from Beijing Weigao Yahua Artificial.


8. SpineView X-pac Expandable Lumbar Cage System from Spine View.


9. Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheter from G21.


10. C-VBR from Cardinal Spine.


11. Rampart A Lumbar Interbody Fusion Device from Spineology.


12. Navigation Instruments from Globus Medical.


13. SmartBase for Arthrex Glenoid IRIS from Custom Orthopaedic Solutions.


14. Alpine Cemented Hip System from Ortho Development.


15. Arthrex Synergy UHD4 System from Arthrex.


16. Fusion Compact Navigation System from Medtronic Navigation.


17. Palisade Pedicular Fixation System from Spineology.


18. Epic Extremity Plate System from Epic Extremity.


19. Caspian OCT/MESA Mini/DENALI Mini Spinal System from K2M.


20. OS2-C Compression Staple from In2Bones.


21. Comprehensive SRS/Nexel Elbow.


22. CD Horizon Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the Stealthstation System, Medtronic Reusable Instruments for Use with the IPC Powerease System, Medtronic Navigated Reusable Instruments for Use with the Stealthstation and IPC Powerease Systems from Medtronic Sofamor Danek.


23. Stryker CMF Medpor Customized Implant from Stryker.


24. Tyber Medical Trauma Screw from Tyber Medical.


25. Arthrex iBalance TKA System from Arthrex.


26. Zimmer Virage OCT Spinal Fixation System from Zimmer Spine.


27. Sniper Spine System from Spine Wave.


28. Optimus ALIF System from Amendia.


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