52 orthopedic devices receive FDA 510(k) clearance in November 2017

Spinal Tech

The FDA granted 52 orthopedic- and spine-related device clearances in November.


1. Fortify Corpectomy Spacers for Globus Medical.


2. IMPIX 3D Print Cages from Medicrea International.


3. Arthrex FiberTape Cerclage from Arthrex.


4. Lucent from Spinal Elements.


5. Medussa-PL Cage from Medyssey USA.


6. C2 Femoral Stem from Limacorporate.


7. Prolixus Total Knee System from Otis Biotech.


8. PIT'Stop implant from In2Bones.


9. M-Vizion Femoral Revision System from Medacta.


10. Hintermann Series H2 Total Ankle System from Dt MedTech.


11. Redapt Augments from Smith & Nephew.


12. Healix Advance Knotless Anchor from Medos International.


13. Arthrex Knee Systems from Arthrex.


14. Renovis Surgical Hip Replacement System from Renovis Surgical Technologies.


15. Birmingham Hip Dual Mobility Insert from Smith & Nephew.


16. Brisbane ALIF Device, Gladstone ALIF Device from Signature Orthopaedics.


17. Arlington PLIF/TLIF Cage from Signature Orthopaedics.


18. Modulift Vertebral Body Replacement System from Aesculap Implants Systems.


19. Materialise Glenoid Positioning System from Materialise.


20. Altus Spine Cervical Interbody Fusion System from Altus Partners.


21. Omni Foot Plating System from Extremity Medical.


22. CoLink View Plating System from In2Bones USA.


23. Mako Partial Knee Application from Mako Surgical.


24. Sovereign Spinal System from Medtronic Sofamor Danek.


25. Lateral Spinal Truss System from 4Web.


26. Velofix SA Cervical Cage from U&I Corporation.


27. Construx Mini PTC Spacer System, Forza PTC Spacer System, Pillard SA PTC Spacer from Orthofix.


28. Epic Extremity Fracture Plate System from Epic Extremity.


29. Spira-C Open Matrix Cervical Interbody from Camber Spine Technologies.


30. OrthAlign Plus System from OrthAlign.


31. TiLock Modular Spinal System from Genesys Spine.


32. Iconn Square 2.5MM Suture Anchor from Iconn Orthopedics.


33. NuVasive AttraX Scaffold from NuVasive.


34. Materialise PKA Guide System from Materialise.


35. Sapphire Cervical Implant System from Sapphire Medical Group.


36. Zimmer Trabecular Metal Reverse Shoulder System, Mini Genoid from Zimmer.


37. Intellijoint HIP System, Intellijoint HIP Intellijoint HIP Instrument Tray from Intellijoint Surgical.


38. Stryker Self-Punching Iconix from Stryker.


39. Destiknee Total Knee System from Meril Healthcare.


40. NuVasive Growth Rod Conversion Set from NuVasive.


41. Vertera Spine Cohere Cervical Interbody Fusion Device from NuVasive.


42. Orthofix MJ-Flex the New Metaizeau Nail from Orthofix.


43. Fortis and Hana Anterior Cervical Plate System from Huvexel.


44. Ankle Fusion Plating System from In2Bone SAS.


45. VariAx 2 System from Stryker.


46. Anthem Fracture System from Globus Medical.


47. Paramount Anterior Cervical Cage System from Spine Wave.


48. Aesculap Slim Clip Applier Forceps from Aesculap.


49. LessRay System from NuVasive.


50. Journey II XR Knee Instruments from Smith & Nephew.


51. ExactechGPS Total Shoulder Application from Blue Ortho.


52. Solanas Posterior Stabilization System from Alphatec Spine.



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