43 spine, orthopedic devices receive FDA 510(k) clearance in January

Written by Laura Dyrda | February 15, 2016 | Print  |

The FDA cleared 43 orthopedic- and spine-related devices in January.

1. Amendia Interbody Fusion Devices from Amendia.


2. VerteLP Interbody Fusion Device from VGI.


3. ARIX Wrist System from Jeil Medical.


4. ROSA Spine from MEDTECH.


5. Ellipse Supplemental Instrument Trays from Ellipse Technologies.


6. Cable-Ready Cable Grip System: Cable-Ready Bone Plate System from Zimmer.


7. AVS AL and AVS Align PEEK, AVS PL and AVS UniLIF PEEK Spacers from Stryker.


8. TriMed Humeral Supracondylar Fixation System from TriMed.


9. Coalition Spacers from Globus Medical.


10. FacetBRIDGE System from LDR Spine.


11. Medtronic Transportation/Sterilization Cassettes from Medtronic Sofamor Danek.


12. FORZA PTC Spacer System from Orthofix.


13. Half Dome Posterior Lumbar Interbody System from Astura Medical.


14. Kyphon HV-R Fenestrated Screw Cement, CD Horizon Fenestrated Screw Set from Medtronic Sofamor Danek USA.


15. Spine Wave Gen II Expandable Interbody System from Spine Wave.


16. Unison-C Anterior Cervical Fixation System from Pioneer Surgical Technology.


17. K2M Fenestrated Tap System from K2M.


18. NuVasiveNVM5 System from NuVasive.


19. Aequalis Fx2 from Tornier.


20. Amendia Stand-Alone Cervical System from Amendia.


21. aap LOQTEQ VA Radius Set 2.5 from aap Implantate.


22. PASS OCT Patient Specific Rods from MEDICREA.


23. Adjustable Fixation Device from ArthroCare.


24. ConforMIS iTotal Posterior Stabilization Knee Replacement System from ConforMIS.


25. Frontier Medical Devices In-Line Orthopedic Cable Cerclage System from Frontier Medical Devices.


26. Epic Extremity Cannulated Screw System from Epic Extremity.


27. VuePoint OCT System from NuVasive.


28. Tiger Cannulated Screw System from Trilliant Surgical.


29. Spine Innovation Interbody System from Spine Innovation.


30. Cornerstone PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK from PREVAIL Cervical Interbody Device.


31. Corin Metafix Hip Stem from Corin USA.


32. Perla Posterior Cervico-Thoracic Fixation system from Spineart.


33. Reprocessed Stryker External Fixation Devices from Stryker Sustainability Solutions.


34. Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System from Orthofix.


35. Senecka II Polyscrew Pedicle Fixation System from Senecka Spine.


36. Treace Medical Concepts Plating System from Treace Medical Concepts.


37. Piccolo Composite Nailing System from Carbofix Orthopedics.


38. Salvation External Fixation System from Wright Medical Technology.


39. M.U.S.T. Pedicle Screw System from MEDACTA.


40. MultiFIX S Ultra Knotless Fixation System from ArthroCare.


41. Stryker Neptune E-SEP Smoke Evacuation Pencil from Stryker.


42. Biomet Spine Fusion System from Biomet Spine.


43. Release Laminoplasty Fixation System from Pioneer Surgical Technology.


More articles on orthopedic devices:
33 spine, orthopedic devices receive FDA 510(k) clearance in December
32 spine, orthopedic devices receive FDA 510(k) clearance November
39 spine, orthopedic devices receive FDA 510(k) clearance


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