47 orthopedic, spine devices receive FDA 510(k) clearance in March 2017

Spinal Tech

The FDA granted 47 orthopedic- and spine-related clearances in March 2017.

1. Medicon Spinal Spreading Systems from Medicon EG.

 

2. U2 Total Knee System E-XPE Products from United Orthopedic Corporation.

 

3. LINK SP-CL Hip System PoroLink and HX coated from Waldemar Link.

 

4. Evolution Revision Tibial Base from MicroPort Orthopedics.

 

5. Salvation External Fixation System from Wright Medical.

 

6. GMK Sphere from Medacta.

 

7. Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins from DePuy Synthes.

 

8. NuVasive Next Generation NVM5 System from NuVasive.

 

9. Exactech Equinoxe Reverse Shoulder Locking Cap from Exactech.

 

10. Intellijoint Hipe Generation 2A System from Intellijoint Surgical.

 

11. ZipE Knotless Tissue Repair and Attachment Devices from Ziptek.

 

12. Move Forward 3D Motion Simulation Service from Biomet.

 

13. Z-Link PC System from Zavation.

 

14. VertebraLINK Fusion Platform from LINKSPINE.

 

15. iFuse Implant System – iFuse-3D implant from SI-BONE.

 

16. Navigated Instrument System from Orthofix.

 

17. Ibis Pedicle Screw System from Ortho Development Corp.

 

18. Y3 Proximal Femoral Plate System from Pega Medical.

 

19. Ortholoc 3Di Small Bones Plating from Wright Medical Technology.

 

20. GPC Brand Posterior, Non-cervical Pedicle Screw Spinal System from GPC Medical.

 

21. NuVasive Modulus XLIF Interbody System from NuVasive.

 

22. Mojave Expandable Interbody System from K2M.

 

23. KneeAlign 2 System from OrthAlign.

 

24. Rampart T Lumbar Interbody Fusion Device from Spineology.

 

25. Cavux CervicalCage-L System from Providence Medical Technology.

 

26. Flex-Thread Clavicle Pin System from Intrafuse.

 

27. OrthoSolutions 'System26' Bone Screws from Ortho Solutions.

 

28. NuVasive CoRoent Small Interbody System from NuVasive.

 

29. EXPRT Revision Hip System, Distal Stem, Standard Offset Proximal Body Implant, Lateral Offset Proximal Body Implant, Capture Bolt from Encore Medical.

 

30. SeaSpine Daytona Small Stature Spinal System from SeaSpine Orthopedics.

 

31. Bodycad Unicompartmental Knee System from Bodycad Laboratories.

 

32. Iconix TT All Suture Anchor from Stryker.

 

33. Level One Hand Plating System from KLS Martin.

 

34. NuVasive Reline 4.5-5.0 System from NuVasive.

 

35. LOSPA IS TLIF & DLIF Cages from Corentec.

 

36. NuVasive Monolith Corpectomy System form NuVasive.

 

37. Alians Clavicle Range from Newclip Technics.

 

38. Parcus SLiK Anchors from Parcus Medical.

 

39. Precice Intramedullary Limb Lengthening System from NuVasive Specialized Orthopedics.

 

40. ToeMATE Hammertoe Correction System from Arthrosurface.

 

41. CrossFT Knotless Biocomposite Suture Anchor with Dispoable Driver from ConMed Corp.

 

42. EndoWrist Stapler 45 Instrument, Reloads, EndoWrist Stapler 30 Instrument, Reloads from Intuitive Surgical.

 

43. Altus Spine Titanium Interbody Fusion System from Altus Partners.

 

44. Sterispine PS from Safe Orthopaedics.

 

45. Butrex Lumbar Buttress Plating System from X-Spine Systems.

 

46. Avitus Bone Harvester with Filter Insert from Avitus Orthopaedics.

 

47. USS System from Synthes USA Products.

 

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