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

Spinal Tech

The FDA granted clearance to 47 orthopedic- and spine-focused devices in March.

1. Arthrex SwiveLock Anchors from Arthrex.

 

2. Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing from Stryker.

 

3. SurgTech Interbody System from SurgTech.

 

4. Exactech Vantage Total Ankle System from Exactech.

 

5. Ventix Knotless Anchors from Biomet.

 

6. UCP Stem from United Orthopedic Corporation.

 

7. MPO Total Knee Systems MR Labeling from MicroPort Orthopedics.

 

8. S-Wire from Spinal Resources.

 

9. iFuse Implant System from SI-BONE.

 

10. Conquest from Smith & Nephew.

 

11. TRYPTIK2C-plate Anterior Cervical Plate System from Spineart.

 

12. OrthAlign Plus System from OrthAlign.

 

13. PEEK Customized Cranial Implant from Stryker.

 

14. Renovis Tesera SC Stand-alone Anterior Cervical Fusion System from Renovis Surgical.

 

15. Erisma-LP Spinal Fixation System from Clariance.

 

16. JAZZ LOCK from Implanet.

 

17. ProLift Expandable System from Life Spine.

 

18. Perimeter C Spinal System from Medtornic Sofamor Danek USA.

 

19. Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System from LDR Spine USA.

 

20. Optetrak Logic Metaphyseal Cones from Exactech.

 

21. ArthrexVIP Web Portal from Custom Orthopaedic Solutions.

 

22. NuVasive TLX Interbody System from NuVasive.

 

23. Truespan Meniscal Repair System from Medos International SARL.

 

24. iTotal Cruciate Retaining Knee Replacement System from ConforMIS.

 

25. Corin TaperFit Hip Stem from Corin USA.

 

26. Straumann Bone Level Tapered Implants from Institut Straumann.

 

27. OS2-VP Verisation Staple from In2Bones.

 

28. Optetrak One Logic Femoral Components from Exactech.

 

29. Corin TriFit TS Hip from Corin USA.

 

30. NuVasive Lumbar Interbody Implants from NuVasive.

 

31. Piccolo Composite Distal Volar Radius Plate System from Carbofix Orthopedics.

 

32. Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System from Captiva Spine.

 

33. iTotal Posterior Stabilization Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System from ConforMIS.

 

34. Biomet Variable Pitch Compression Screw System from Biomet.

 

35. Sonoma Fibula Repair System from Sonoma Orthopedics.

 

36. Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomic Shoulder Fracture System from Zimmer.

 

37. Xspan Laminoplasty Fixation System from X-Spine.

 

38. Nile Alternative Fixation Spinal System from K2M.

 

39. Align Anterior Ankle Fusion Plate from Extremity Medical.

 

40. Precice Trauma Nail System from Ellipse Technologies.

 

41. Z-Span Plate System from Zavation.

 

42. AOS Anterolateral Proximal Humeral Plate from Advanced Orthopaedic Solutions.

 

43. Perimeter Interbody Fusion Device from Medtronic Sofamor Danek.

 

44. Response 5.5 Spine System from Orthopediatrics.

 

45. Optetrak Advanced Patella from Exactech.

 

46. Anatomic PEEK PTC Cervical Fusion System from Medtronic Sofamor Danek.

 

47. Cascadia Interbody System from K2M.

 

More articles on FDA clearances:

28 spine, orthopedic devices receive FDA 510(k) clearance in February
43 spine, orthopedic devices receive FDA 510(k) clearance in January
33 spine, orthopedic devices receive FDA 510(k) clearance in December

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