48 orthopedic devices receive FDA 510(k) clearance in May 2017

Spinal Tech

The FDA granted 48 orthopedic- related device clearances in May.

 

1. Maluc Total Hip Arthroplasty System from SurgTech.

 

2. VerteFIT Corpectomy Cage System from LDR Spine.

 

3. Divergence-L Anterior/Oblique Lumbar Fusion System from Medtronic Sofamor Danek.

 

4. The Cranial Fusion System from Life Spine.

 

5. Locking Plate System from Beijing Keyi Medical Device Technologies.

 

6. Foundation 3D Interbody from CoreLink.

 

7. NuVasive NuvaLine Mobile App from NuVasive.

 

8. Captive Compression Screws from Globus Medical.

 

9. Spinel 12HD Interventional Fluoroscopic Mobile X-ray System from GeMSS Medical Systems.

 

10. Translace Spinal Tethering System from Medtronic Sofamor Danek USA.

 

11. Colink Plating System from In2BoneUSA.

 

12. Half Dome Posterior Lumbar Interbody System from Astura Medical.

 

13. Vitoss Bioactive Injectable from Orthovita.

 

14. Humeris Shoulder from Fx Solutions.

 

15. Rampart One Lumbar Interbody Fusion Device from Spineology.

 

16. Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor from Nanova Biomaterials.

 

17. Fortilink-C with Tetrafuse 3D Technology from RTI Surgical.

 

18. NuVasive CoRoent Ti-C System from NuVasive.

 

19. StealthStation S8 Spine Software v1.0.0 from Medtronic Navigation.

 

20. Xultan 5.5 Pedicle Screw System from Met One Technologies.

 

21. UNiD Spine Analyzer from Medicrea International.

 

22. Smith & Nephew Visionaire Adaptive Guides from Smith & Nephew.

 

23. Ocata Anterior Cervical System from Kalitec Direct.

 

24. Blue Belt Technologies from Navio.

 

25. Collagen Meniscus Implant from Ivy Sports Medicine.

 

26. Arthrex Compression Screws from Arthrex.

 

27. Piccolo Composite Plate System from CarboFix Orthopedics.

 

28. KISSloc Suture System from Arthrosurface.

 

29. Xia 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory from Stryker.

 

30. Viper Prime Screws with Fenestrations from Medos International.

 

31. Empor CR Knee Tibial Insert from Encore Medical.

 

32. Mako Total Knee Application from MAKO Surgical.

 

33. Mako Partial Knee Application from MAKO Surgical.

 

34. I.B.S. osteosynthesis screws rom In2Bones.

 

35. SETx Pedicle Screw System from Xenco Medical.

 

36. Anthem CR Total Knee System from Smith & Nephew.

 

37. Orthofix TrueLok Hexapod System from Orthofix.

 

38. CD Horizon Spinal System, Medtronic Reusable Instruments from Medtronic.

 

39. Ally Bone Screws from Providence Medical Technology.

 

40. VariAx 2 Foot System from Stryker.

 

41. The Solstice OCT System from Life Spine.

 

42. Mako Partial Knee Application from MAKO Surgical.

 

43. Dymaxeon Spine System from Back 2 Basics Direct.

 

44. Arthrex Knotless SutureTak Anchor from Arthrex.

 

45. Firebird Spinal Fixation System from Orthofix.

 

46. Mojave Expandable Interbody System from K2M.

 

47. Arthrex SwiveLock Anchors from Arthrex.

 

48. M.U.S.T. Pedicle Screw System from Medacta International.

 

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm561793.htm

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