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

Laura Dyrda -   Print  |

The FDA cleared 28 orthopedic and spine related devices in June.

1. Spinal Fixation System from Shangdon Kangsheng Medical Device.
2. Cemented TSI Hip Stem from Signature Orthopaedics.
3. Kinos Axiom Total ankle System from Kinos Medical.
4. The Inbone Total Ankle System, the Infinity Total Ankle System and the Invision Total Ankle Revision System from Wright Medical Technology.
5. Naviswiss Hip Navigation System from Naviswiss.
6. SpineFrontier Lumbar Interbody Fusion Device System from SpineFrontier.
7. Arthrex DynaNite K-Wire from Arthrex.
8. F3D Cervical Stand-Alone Interbody Fusion System from CoreLink.
9. Journey II XR Knee Instrument from Smith & Nephew.
10. Medussa-PL Cage from Medyssey USA.
11. IlluminOss Bone Stabilization System from IlluminOss Medical.
12. Altus Spine Pedicle Screw System from Altus Partners.
13. AxSOS 3 AF System and AxSOS 3 Ti System from Stryker.
14. Signature ONE System from Orthosoft.
15. Rigel 3DR Anterior Cervical Interbody Fusion System from MiRus.
16. Lever Action Plate System from McGinley Orthopaedic Innovations.
17. DuoHex CH Cannulated Hammertoe System from Nextremity Solutions.
18. SeaSpine Meridian System, SeaSpine Regatta Lateral System from SeaSpine Orthopedics.
19. CarboClear Cervical Plate System from Carbofix Orthopedics.
20. OMNIBiotics Knee System from Corin.
21. Harvey Surgical Assistant from OrthAlign.
22. iTotal Identity Posterior Stabilized Knee Replacement System from Conformis.
23. Sapphire Spinal System, Sapphire X Anterior Cervical Plate Spinal System from Spinal Elements.
24. TSolution One Total Knee Application from THINK Surgical.
25. DePuy Attune Total Knee System from DePuy Orthopaedics.
26. InFrame Cannulated Fixation System from ExsoMed.
27. Centurion POCT System from Orthofix.
28. Cadence Total Ankle System from Integra LifeSciences.

More articles on devices:
Setting spine practices up for success post-pandemic: 5 industry insights
UAMS begins data gathering initiative with spine patients
3 spine surgeons on the move in June

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