41 orthopedic devices receive FDA 510(k) clearance in March

Written by Laura Dyrda | April 13, 2018 | Print  |

The FDA granted 41 orthopedic- and spine-related clearances in March.

1. Acculoc Total Knee System from RootLoc.

2. Puma System from Panther Orthopedics.

3. HammerToe System from Paragon  28.

4. TDM Plate and Screw System from TDM.

5. Arthrex Shoulder System from Arthrex.

6. Mpact 3D Metal Implants and Augments 3D Metal from Medacta.

7. Navigated Instrument System from Orthofix.

8. Anchorage Bone Plating System from Stryker.

9. CoreHip System from Aesculap Implants Systems.

10. Irene Thoracolumbar Fixation System from Tianjin Zhengtian Medical Instruments.

11. Fortress Radiopaque Bone Cement, Creo Fenestrated Screw System, Revlok Fenestrated Screw System from Globus Medical.

12. Arthrex Univers Revers Coated Baseplate from Arthrex.

13. Footmotion HammerToe from Newclip Technics.

14. DePuy Synthes Femoral Neck System from DePuy Synthes.

15. Zimmer Knee Joint Replacement Prostheses MR Labeling from Zimmer.

16. Arco-SA Lumbar Cage System from NeuroStructures.

17. Sentio MMG Pedicle Access Needless from Medos International.

18. Mega Plus Spine System from BK Meditech.

19. CD Horizon Spinal System from Medtronic Sofamor Danek.

20. Exactech Equinoxe Stemless Shoulder from Exactech.

21. Valeo C+CSC with Lumen Interbody Fusion Device from Amedica.

22. Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads from Stryker.

23. Exactech Novation and AcuMatch E-HXL Acetabular Liners from Exactech.

24. Empor Universal Tibial Baseplate from Encore Medical.

25. SI Screw System from Zavation Medical Products.

26. Arthrex Corkscrew from Arthrex.

27. AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared from Medacta.

28. Triway Tibiotalocalcaneal Arthrodesis System from In2Bones.

29. Catalyst CSR 3 Peg Glenoids from Catalyst OrthoScience.

30. Genesys Spine AIS-C Cervical Anchored Interbody System from Genesys Spine.

31. X-spine Cortical Bone Screw System from X-spine Systems.

32. SP-Fix Spinous Process Fixation Plate, Relieve Laminoplasty Fixation System from Globus Medical.

33. Klassic Knee System from Total Joint Orthopedics.

34. NuVasive VuewPoint II OCT System from NuVasive.

35. Polaris Spinal Growth System from Zimmer Biomet Spine.

36. Ventix Link Knotless Anchor with Inserter from Cayenne Medical.

37. Legion Knee System from Smith & Nephew.

38. Cortina Lumbar Cage System from NeuroStructures.

39. CapLOX II / TowerLOX MIS Pedicle Screw System from Captiva Spine.

40. Zavation Buttress Plate System from Zavation Medical.

41. G-scan Brio from Esaote.


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