43 orthopedic, spine devices receive FDA 510(k) clearance in November 2016

Spinal Tech

The FDA granted 43 510(k) orthopedic- and spine-related device clearances in November 2016.

1. PathLoc-SI Joint Fusion System from L&K Biomed.


2. Lumbar Interbody Fusion System from Evolution Spine.


3. Initia Total Hip System & Bioceram Azul Head from Kyocera Medical Corp.


4. Amendia Interbody Fusion Devices from Amendia.


5. Xert Lumbar Expandable Interbody System from X-Spine Systems.


6. Trigen Low Profile Bone Screws from Smith & Nephew.


7. DePuy Synthes Maxframe Multi-Axial Correction System from Synthes USA.


8. Genesys Spine Apache Anterior Lumbar Interbody Fusion System from Genesys Spine.


9. MatrixRIB Fixation System from Synthes USA Products.


10. Exprt Revision Hip System from Encore Medical.


11. Anatomical Shoulder Domelock Dome Centric from Zimmer.


12. Virtu C Spine Implant System from Met 1 Technologies.


13. VLP Wrist Fracture System from Smith & Nephew.


14. aap Loteq Distal Lateral Humerus Plate 2.7/3.5 from aap Implantate.


15. Loqteq Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer from aap Implantate.


16. Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid from Tornier.


17. Hoffman LRF System from Stryker.


18. Smith & Nephew Truclear Ultra Mini Tissue Removal Device from Smith & Nephew.


19. ToeTac 10 Hammertoe Fixation System from Restore Surgical.


20. Arthrex Univers Revers Shoulder Prosthesis System from Arthrex.


21. ReUnion Reversible Fracture System, ReUnion Reverse Shoulder Arthroplasty, ReUnion Total Shoulder Arthroplasty from Stryker.


22. AOS Small Fragment Plating System from Advanced Orthopaedic Solutions.


23. Leva Anterior Interbody System from Spine Wave.


24. AltiVate Anatomic Shoulder System from Encore Medical.


25. AVAmax Vertebral Balloon, AVAflex Vertebral Balloon from Stryker.


26. EVOS Small Bone Fragment Plating System from Smith & Nephew.


27. Choice Spine Lumbar Spacer, Choice Spine Interbody Fusion System, Choice Spine Vertebral Body Replacement System from Choice Spine.


28. CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System from L&K Biomed.


29. Preference Elite Pedicle Screw System from Amedica.


30. AccuFit Lateral Plate System from Precision Spine.


31. Dio Medical IVA (ACIF, DLIF, PLIF, TLIF and ALIF) Cage from Dio Medical.


32. Moss 100 Pedicle Screw System from Biedermann Motech.


33. Tritanium PL Cage from Stryker.


34. Materialise TKA Guide System from Materialise.


35. Reform POCT System from Precision Spine.


36. T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System from Synthes USA.


37. Luna 3D Interbody Fusion System from Benvenue Medical.


38. 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) from Pan Medical.


39. Fortezza Spinal Stabilization System from OSSO Surgical.


40. CastleLoc Spinal Fixation System from L&K Biomed.


41. ds Small Extremity 16CH 1.5T coil from InVivo Therapeutics.


42. Irix-C Cervical Integrated Fusion System from X-Spine Systems.


43. TxRx Knee 15 Flare MR Coil 1.5T, 3.0T from Quality Electrodynamics.


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