35 Spine & Orthopedic Devices Receive FDA 510(k) Clearance in January

Spinal Tech


InstrumentsThe Food and Drug Administration granted 35 orthopedic- and spine-related device clearances in January.



1. SpineFrontier A-CIFT Colofuse Cervical Intervertebral Fusion Device System from SpineFrontier.


2. OrthoHelix Syndesmosis Fixation Devices from OrthoHelix Surgical Designs.


3. Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System from Medtronic Sofamor Danek.


4. Lateral Synfix from Synthes Products.


5. Acumed Hand Plating System from Acumed.


6. Distalock Tibial IM Nail System from DGIMED Ortho.


7. D-Rad Smart Pack from Smith & Nephew.


8. Axia Radial Head System from Innovation Medical Device.


9. Midline from Centinel Spine.


10. iTotal Cruciate Retaining, iUni Unicondylar Knee Replacement Systems from ConforMIS.


11. Rampart-L from Spineology.


12. DigiFix External Fixation System from Virak Orthopedic Research.


13. Santis Pedicle Screw System from Lanterna Medical Technologies.


14. SpineSelect Polyscrew Pedicle Screw System from SpineSelect.



15. Tiger Spine System from Coreline.


16. U2 Tibial Baseplate from United Orthopedic Corporation.



17. Optio-C Anterior Cervical System from Zimmer Spine.


18. Dynesys Top-Loading Spinal System from Zimmer Spine.


19. Q-Fix Suture Anchor from ArthroCare.


20. Synapse System from Synthes USA Products.


21. Bone Fragment and Fixation Plates, Screws and Washers from Internal Fixation Systems.


22. Iconacy I-Hip System, Gradual Transitioning Femoral System from Iconacy Orthopedic Implants.


23. The Kinegraph Vertebral Motion Analyzer Software Version 2.2 from Ortho Kinematics.


24. Kestrel Posterior Cervical Spine System from OMNI Surgical.


25. JTS Extendible Distal Femoral Implant from Stanmore Implants Worldwide.


26. Aesculap PEEK XP Spinal Implant System from Aesculap Implant Systems.


27. Biomet Stave One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis from Biomet.


28. AAP Loqteq Distal Anterolateral Tibia Plate 3.5 from aap Implantate.


29. Kiva VCF Treatment System from Benvenue Medical.


30. Aversion Pedicle Screw System from K7.


31. XtraFit Small External Fixation System from Zimmer.


32. Centurion POCT System from Orthofix.


33. Ardis Interbody System from Zimmer Spine.


34. Arthrex Biosuture from Arthrex.


35. Mixing Syringe System from Zimmer Knee Creations.


More Articles on Device Clearances:
44 Spine & Orthopedic Devices Receive FDA 510(k) Clearance in December
10 Spine Devices Receive FDA 510(k) Clearance in November
17 Spine Devices Receive FDA 510(k) Clearance in October


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