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59 orthopedic devices receive FDA 510(k) clearance in December Featured

By  Laura Dyrda | Friday, 12 January 2018 07:28
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The FDA cleared 59 orthopedic devices in December 2017.

 

1. Taurus PEEK Cage System from Medyssey USA.

 

2. Arthrex Univers Revers Apex Humeral Stems from Arthrex.

 

3. Altus Spine Interbody Fusion System from Altus Partners.

 

4. Apex Tibial Nailing System from OrthoXel.

 

5. Medacta Shoulder System: Threaded Glenoid Baseplate from Medacta.

 

6. X-PSI Knee System from Orthosoft.

 

7. G Surgical OCT Spinal System from G Surgical.

 

8. Fortify and Fortify Integrated Corpectomy Spacers from Globus Medical.

 

9. XPand Corpectomy Spacers from Globus Medical.

 

10. Niko Corpectomy spacers from Globus Medical.

 

11. Sustain Spacers from Globus Medical.

 

12. Coalition Spacers from Globus Medical.

 

13. Patriot Lumbar Spacers and Cervical Spacers from Globus Medical.

 

14. Altera Spacers from Globus Medical.

 

15. Caliber Spacers from Globus Medical.

 

16. Elsa Spacers from Globus Medical.

 

17. Latis Spacers from Globus Medical.

 

18. Monument Spacers from Globus Medical.

 

19. InterContinental Plate-Spacer from Globus Medical.

 

20. Independence Spacers from Globus Medical.

 

21. Sidus Stem-Free Shoulder from Zimmer.

 

22. Arix Humerus System from Jeil Medical.

 

23. Cascadia Interbody System from K2M.

 

24. Arthrex DynaNite Nitinol Staple from Arthrex.

 

25. Tyber Medical PT Interbody Spacer System from Tyber Medical.

 

26. InFill Interbody Fusion Device from Pinnacle Spine Group.

 

27. AxSOS 3 Ti from Stryker.

 

28. Arthrosurface Bone Screws from Arthrosurface.

 

29. Velofix TLIF Cage from U&I Corp.

 

30. OrthoPediatrics Wrist Fusion Plate from OrthoPediatrics.

 

31. OMNI ARC Anteverted Neck Hip Stem from OMNIlife Science.

 

32. Proficient Posterior Cervical Spine System from Spine Wave.

 

33. NuVasive Navigation Instruments from NuVasive.

 

34. NuVasive Modulus-C Interbody System from NuVasive.

 

35. Align Radial Head System from Skeletal Dynamics.

 

36. Varian Cage from Medyssey USA.

 

37. Conquest from Smith & Nephew.

 

38. SeaSpine Vu cPOD, Zuma-C, Complete Cervical from SeaSpine.

 

39. Life Spine Foot and Ankle Plating System from Life Spine.

 

40. WishBone K-Wire System from WishBone Medical.

 

41. Boundary Anterior Lumbar Buttress Plate from Nvision Biomedical Technologies.

 

42. Reliance Cervical IBF System from Reliance Medical Systems.

 

43. NuVasive VersaTie System from NuVasive.

 

44. T2 Stratosphere Expandable Corpectomy System from Medtronic Sofamor Danek.

 

45. Arisstos Spinal System from Ingenium Spine.

 

46. Precice System from NuVasive.

 

47. Reform Midline Corticle Screw System from Precision Spine.

 

48. Rexious Spinal Fixation System from Huvexel.

 

49. ACIF from Cologne.

 

50. Vertera Spine Coalesce Thoracolumar Interbody Fusion System from NuVasive.

 

51. ProLift Expandable System from Life Spine.

 

52. SeaSpine Spacer System from SeaSpine Orthopedics.

 

53. MasterLoc Stem: Lateralized Plus from Medacta.

 

54. Cannulated Screw Internal Fixation System from Life Spine.

 

55. Anterior Cervical Plate System from Evolution Spine.

 

56. CorticaLINK Spinal Fusion Platform from LinkSPINE.

 

57. Anax 5.5 Spinal System from U&I Corporation.

 

58. Piccolo Composite Nailing System from CarboFix Orthopedics.

 

59. Medtronic O-arm O2 Imaging System from Medtronic.

 

More articles on FDA clearances:
52 orthopedic devices receive FDA 510(k) clearance in November 2017
40 orthopedic devices receive FDA 510(k) clearance in October
35 orthopedic devices receive FDA 510(k) clearance in September

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