42 spine, orthopedic devices receive FDA 510(k) clearance in September

Spinal Tech

The Food and Drug Administration granted 42 orthopedic- and spine-related clearances in September.

1. Exactech Novation Crown Cup from Exactech.


2. Partial Knee Application from MAKO Surgical.


3. Ackermann Intervertebral Body Fusion Device from Ackermann Instrumente.


4. Bluefin Interbody System from Tides Medical.


5. Benefix Interspinous Fixation System from U&I Corporation.


6. Hedgehog Cervical Interbody Fusion Device from Vertera.


7. Synthetic Bone Graft from OrthoGem.


8. CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System from Orthofix.


9. LDR Spine RIO-C Cervical Cage System from LDR.


10. JuggerKnot Soft Anchors from Biomet.


11. Genesys Spine Apache Cervical Interbody Fusion System from Genesys Spine.


12. U2 Total Knee System - Additional Sizes from United Orthopedic.


13. U2 Femoral Component CR, Porous Coated, Additional Sizes from United Orthopedics.


14. DePuy Actis Dufox Hip Prosthesis from DePuy Orthopaedics.


15. NuVasive PEEK Corpectomy System from NuVasive.


16. OsteoMed IMF Screw from OsteoMed.


17. CrossTIE Intraosseous Fixation System from CrossRoads Extremity Systems.


18. Aequalis Ascend Flex Shoulder, Reverse Shoulder Prosthesis from Tornier.


19. Amendia Interbody Fusion Devices from Amendia.


20. Klassic HD Hip System from Total Joint Orthopedics.


21. Total Compression Plating System from Wright Medical Technology.


22. NuVasive CoRoent Lumbar System from NuVasive.


23. NuVasive PEEK Corpectomy Railed System from NuVasive.


24. Gemmed Pedicle Screw Spinal System from Suzhou Gemmed Medical Instrument.


25. NuVasive X-CORE Mini Cervical Expandable VBR System from NuVasive.


26. Romeo Posterior Osteosynthesis System from Spineart.


27. Lotus Posterior Cervical/Thoracic Spinal System from Spinal Elements.


28. Everest Spinal System from K2M.


29. Xenco Medical Pedicle Screw System from Xenco Medical.


30. PRO-TOE Hammertoe Fixation System from Wright Medical Technology.


31. Seneka I Polyscrew Pedicle Fixation System from Seneka Spine.


32. Summit SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System from DePuy Synthes.


33. REDAPT Revision Femoral System from Smith & Nephew.


34. Pyrenees Cervical Plate System from K2M.


35. Reliance Spinal Screw System from Reliance Medical Systems.


36. X-spine Pedicle Screw System from X-Spine Systems.


37. Fortress Pedicular Fixation System from Spineology.


38. ARIX Ankle System from Jeil Medical.


39. Exactech Optetrak Logic Enhanced Assembly from Exactech.


40. Orthofix TL-HEX True Lox Hexapod System from Orthofix.


41. Renovis Anterior Cervical Plate System from Renovis Surgical Technologies.


42. Xenco Medical Cervical Interbody System from Xenco Medical.



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