38 orthopedic devices receive FDA 510(k) clearance in February

Written by Laura Dyrda | March 06, 2019 | Print  |

The FDA cleared 38 orthopedics-related devices in February.

 

1. TEMA Elbow System from Lima Corporate.

2. MIS Bunion System from CrossRoads Extremity Systems.

3. Precice Bone Transport System from NuVasive Specialized Orthopedics.

4. PhantomMSK from OrthoGrid Systems.

5. Altus Spine Interbody Fusion System from Altus Partners.

6. DynaNail Mini from Medshape.

7. Juveno Hip System Femoral Stem, B-ONE Primary Acetabular System Cups from b-ONE Ortho.

8. Atlantis Anterior Cervical Plate, Divergence Anterior Cervical Fusion System from Medtronic Sofamor Danek.

9. Divergence Anterior Cervical Fusion System from Medtronic Sofamor Danek.

10. Premier Anterior Cervical Plate from Medtronic Sofamor Danek.

11. Venture Anterior Cervical Plate from Medtronic Sofamor Danek.

12. Zephir Anterior Cervical Plate System from Medtronic Sofamor Danek.

13. Zevo Anterior Cervical Plate System from Medtronic Sofamor Danek.

14. Healix Advance SP PEEK Anchor from Medos International.

15. NuVasive Reline System from NuVasive.

16. Epic Extremity Fusion Plate System from Epic Extremity.

17. ReUnion Reversible Fracture System from Stryker.

18. ReUnion Reverse Shoulder Arthroplasty System from Stryker.

19. ReUnion Total Shoulder Arthroplasty System from Stryker.

20. Reliance Lumbar IBF System from Reliance Medical Systems.

21. Vector Hammertoe Correction System from Nvision Biomedical Technologies.

22. SMG Anterior Cervical Plate System from Sapphire Medical Group.

23. Spectra Optia Apheresis System from Terumo BCT.

24. Shoreline Cervical Interbody RT System from SeaSpine Orthopedics.

25. SI-LOK Sacroiliac Joint Fixation System, Navigation instruments, Excelsius GPS Instruments from Globus Medical.

26. Link MP Monoblock Hip Prosthesis from Waldemar Link.

27. Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy
Trackers and Fluoroscopy Adapters, SpineMask Tracker from Stryker.

28. Stabil Orthopaedic Solutions Total Knee System from Stabil Orthopaedic Solutions.

29. Healix Ti Anchor with Dynacord from Medos International.

30. Libertas Acetabular Hooded Liner from Maxx Orthopedics.

31. Athena II Cervical Plate System from Medyssey USA.

32. Endoskeleton TA Interbody Fusion Device, Endoskeleton TA Vertebral Body Replacement Device from Titan Spine.

33. Choice Spine Hawkeye Vertebral Body Replacement from ChoiceSpine.

34. Omnia Medical Rotary PLIF System from Omnia Medical.

35. Velofix Interbody Fusion System from U&I Corp.

36. Perla Posterior Cervico-Thoracic Fixation System from Spineart.

37. Journey II Unicompartmental Knee System from Smith & Nephew.

38. Pedimax II Pedicular Screw Spinal System from Gm Dos Reis Industria E Comerico.

More articles on orthopedic devices:
10 device company key notes
The spine surgery devices, techniques that won't stand the test of time
Is an acquisition in NuVasive's future? CEO Chris Barry on sale rumors, new spine robot

© Copyright ASC COMMUNICATIONS 2019. Interested in LINKING to or REPRINTING this content? View our policies here.

Top 40 Articles from the Past 6 Months