33 spine, orthopedic devices receive FDA 510(k) clearance in October 2016

Spinal Tech

The FDA granted 33 orthopedic- and spine-related clearances in October.

1. Rampart D. Lumbar Interbody Fusion Device from Spineology.


2. XCage Interbody Fusion System from Ouroboros Medical.


3. I.B.S. 2.0 Osteosynthesis screw from In2Bones.


4. Xenco Medical Cervical Interbody System from Xenco Medical.


5. MAGEC Spinal Bracing and Distraction System from NuVasive.


6. LumFix Spinal Fixation System from CG BIO.


7. Z-Clamp ISP System from Zavation.


8. Klassic HD Hip System from Total Joint Orthopedics.


9. iNSitu Total Hip System from Theken Companies.


10. PLEX Elite 9000 SS-OCT from Carl Zeiss Meditec.


11. NeoSpan Compression Staple Implant with instruments from In2Bone USA.


12. Footmotion Plating System from NewClip Technics.


13. HammerTech Fixation System from Fusion Orthopedics.


14. Karl Storz Nav1 Electromagnetic Navigation System from Karl Storz Endoscopy.


15. Trident II Tritanium Acetabular Shells and 6.5 mm Low Profile Hex Screws from Howmedica Osteonics.


16. Cavux Cervical Cage from Providence Medical Technology.


17. kneeEOS from ONEFIT Medical.


18. Zimmer M/L Taper Hip Prosthesis from Zimmer.


19. Overwatch Sypine System from Amendia.


20. Neuromonitoring kit from SI-BONE.


21. G-scan Brio, S-scan from Esaote.


22. M.U.S.T. Pedicle Screw System from Medacta.


23. NuVasive CoRoent Small Ti-C System from NuVasive.


24. FortiBridge Anterior Cervical Plate System from Nanovis Spine.


25. Stryker OrthoMap Precision Knee system from Stryker Leibinger.


26. Kator Suture Anchor from Kator.


27. Klassic Knee System from Total Joint Orthopedics.


28. Firefly Pedicle Screw Navigation Guide from Mighty Oak Medical.


29. Ulna Plating System from Biomet.


30. Distal Radius Plating System from Miami Device Solutions.


31. Pyrenees Cervical Plate System from K2M.


32. SeaSpine Spacer System-Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene from SeaSpine Orthopedics.


33. Libra Pedicle Screw System from Spinal Balance.


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