39 Spine, Orthopedic Devices Receive FDA 510(k) Clearance in May

Spinal Tech

The Food and Drug Administration granted 39 spine- and orthopedic-related device clearances in May.

1. Stabilization Screw from In2Bones.


2. XCage Interbody Fusion System from Ouroboros Medical.


3. Orthopedic Fixation Systems from Impact Medical.


4. Integra Expandable Intervertebral Body Fusion Device System from SeaSpine.


5. NuVasive EMG Endotracheal Tube from NuVasive.


6. MatrixRib Fixation System from Synthes.


7. Swift-Lock Anchor from St. Jude Medical.


8. InFill Cervical from Pinnacle Spine Group.


9. Evos Mini-Fragment Plating System from Smith & Nephew.


10. Excella III-D Spinal Deformity System from Innovasis.


11. True Spinal Fusion System from Innovative Surgical Designs.


12. Stalif C from Centinel Spine.


13. aap Loqtec Olecranon Plate form aap Implantate.


14. Zimmer Trabecular Metal Reverse Shoulder System from Zimmer.


15. One-Piece PEEK Fusion Implant from MTP Solutions.


16. DVR Dorsal Plate, DVR Lateral Plate, DVR Ulna Plate from Biomet.


17. SpineFrontier RedFuse Pedicle Screw System from SpineFrontier.


19. Neoplate Spine Anterior Fixation System from Neoortho Products Orthopedics.


20. MSP Metatarsal Shortening System from Nextremity Solutions.

21. Multifix S Knotless Fixation System from ArthroCare.


22. Charlotte Carolina Jones Fracture System Screw from Wright Medical Technology.


23. Smith & Nephew Cannulated Captured Screw from Smith & Nephew.


24. NuVasive NVM5 System from NuVasive.


25. Klassic Knee Tibial Stem Extension from Total Joint Orthopedics.


26. CS2 Multi-Hole Acetabular Shell from Consensus Orthopedics.


27. Acumed Suture Anchor System from Acumed.


28. Romeo Posterior Osteosynthesis System from Spineart.


29. Trinica Anterior Lumbar Plate System from Zimmer Spine.


31. Zimmer Patient Specific Instruments from Materialise.


32. Everest Spinal System from K2M.


33. Navigated CD Horizon Solera Screwdriver/TAPS from Medtronic Sofamor Danek USA.


34. Salvation 2DI Plating System from Wright Medical Technology.


35. MySpine Pedicle Screw Placement Guides from Medacta.


36. iTotal Cruciate Retaining Knee Replacement System from ConforMIS.


37. Skyhawk Interbody Fusion System from Orthofix.


38. Biomet Side Access Distal Femoral Expandable from Biomet.


39. PEEK Cage for the Vertebral Spine from Neoortho Produtos Ortopedicos.


More Articles on FDA Clearances:
44 Spine, Orthopedic Devices Receive FDA 510(k) Clearance in April
44 Spine, Orthopedic Devices Receive FD A510(k) Clearance in March
31 Spine & Orthopedic Devices Receive FDA 510(k) Clearance in February


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