44 orthopedic, spine devices receive FDA 510(k) clearance in July

Written by Laura Dyrda | August 07, 2018 | Print  |

The FDA cleared 44 orthopedic-and spine-related devices in July 2018.


1. Latitud Hip Replacement System from Meril Healthcare.

2. TruMatch CMF Titanium 3D Printed Implant from Materialise.

3. CarboClear Pedicle Screw System from CarboFix Orthopedics.

4. Jasper Spinal Fixation System from GBS Commonwealth.

5. Arthrex FibuLock Nail from Arthrex.

6. Biolox delta Option and Extra-long Heads from MicroPort Orthopedics.

7. PEEKplus Interbody Fusion Device from Vallum Corp.

8. Lumbar Interbody Fusion System from Advanced Research Medical.

9. Materialise PKA Guide System from Materialise.

10. Athena Cervical Plate System from Medyssey USA.

11. Salvation Midfoot Nail from Wright Medical Technology.

12. Ti 3z Interbody System from Zavation Medical Products.

13. Trend II Spinal Fixation System – STEP Series from Paonan.

14. EcoFit Vit E Acetabular System from implantcast.

15. Field Orthopaedics Micro Screw System from Field Orthopaedics.

16. Corelink Foundation 3D Anterior Lumbar System from Corelink.

17. DePuy Synthes Static Staples from Synthes USA Products.

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

19. Exactech Equinoxe Small Reverse Shoulder System from Exactech.

20. Viking Lumbar Polyaxial Screw System from Presidio Surgical.

21. Normandy VBR System from Zavation Medical.

22. Invision Total Ankle Revision System from Wright Medical Technology.

23. Vail ALIF Buttress Plate System from Evolution Spine.

24. Prime Acetabular Cup System from MicroPort Orthopedics.

25. Empor VVC Tibial Insert from Encore Medical.

26. Tritanium PL Cage from Stryker Spine.

27. Rubicon Lumbar Interbody Fusion System from Rubicon Spine.

28. Stryker All-PEEK Knotless Anchor System from Stryker.

29. CxHA PEEK Cervical IBF System from Innovasis.

30. Olympic Posterior Spinal Fixation System from Astura Medical.

31. OIC Intramedullary Nail System from The Orthopaedic Implant Company.

32. Zavation Cervical Plate System from Zavation Medical.

33. Zavation IBF System from Zavation Medical Products.

34. Curiteva Cervical Interbody Fusion System from Curiteva.

35. Catalyst CSR Shoulder System from Catalyst OrthoScience.

36. Altus Spine Pedicle Screw System from Altus Partners.

37. Astra-OCT Spine System from SpineCraft.

38. Apex Femoral Nailing System from OrthoXel.

39. Firefly Pedicle Screw Navigation Guide from Mighty Oak Medical.

40. Proficient Posterior Cervical Spine System from Spine Wave.

41. ATEC ALIF Spacer System from Alphatec Spine.

42. Republic Spine Dark Star Spinal System from Republic Spine.

43. Stowe Pedicle Screw System from Black Box Medical.

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

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