35 orthopedic devices receive FDA 510(k) clearance in May

Spinal Tech

The FDA cleared 35 orthopedic-related devices in May.

1. KeYi Total Hip Systems from Beijing KeYi Medical Device Technology.
2. MiRus 3d Printed Lumbar Interbody Fusion Systems from MiRus.
3. Joline Kyphoplasty System Allevo from Joline.
4. Optimized Positioning System Insight from Corin.
5. Dymaxeon Spine System from Back 2 Basics Direct.
6. Precice Bone Transport System from NuVasive Specialized Orthopedics.
7. Biocore9 Humeral Resurfacing System form Biocore9.
8. Restoration Modular Hip System from Howmedica Osteonics.
9. VADERone Pedicle System MIS and LIghtMore Pedicle System 6.0 form Icotec.
10. Audere Lumbar Spacer System from Met One Technologies.
11. Precice Screws from NuVasive Specialized Orthopedics.
12. Anterior Spine Truss System – Stand Alone Interbody Fusion Device from 4Web.
13. InCore MPJ System from Nextremity Solutions.
14. JPS JuniOrtho Plating System from Orthofix.
15. Headless Compression Screw System from OsteoCentric Extremities.
16. Reform Pedicle Screw System from Precision Spine.
17. Axis Spine Technologies ALIF from Axis Spine Technologies.
18. Distal Humerus Plating System from Skeleton Dynamics.
19. LOSPA II Knee System from Corentec.
20. ROSA ONE Brain application form Medtech.
21. PERLA Posterior Occipito-Cervico-Thoracic Fixation System from Spineart.
22. O-Genesis Graft Delivery System from Orthofix.
23. AMF Revision TT Cones from LimaCorporate.
24. Skeletal Dynamics Midshaft Humerus Plating System from Skeletal Dynamics.
25. Balteum Lumbar Plate System from Huvexel.
26. Meridian Anterior Plate System, Regatta Lateral Plate System from SeaSpine Orthopedics.
27. Healix Compression Screw System from Nvision Biomedical Technologies.
28. Mazor X from Mazor Robotics.
29. Invictus CT Spinal Fixation System from Alphatec Spine.
30. NuVasive Thoracolumbar Plates from NuVasive.
31. Nexxt Matrixx System from Nexxt Spine.
32. EVOL Spinal Interbody System from Cutting Edge Spine.
33. Insignia Anterior Cervical Plate System from Alphatec Spine.
34. NuVasive ACP System from NuVasive.
35. Cure Lumbar Plate System from Meditech Spine.

More articles on orthopedic devices:
Medtronic's pipeline includes spine, robotics innovations despite pandemic setbacks
3 spine, neurosurgery device recalls in the past year
Aetna to cover sacroiliac joint fusion under new policy

Copyright © 2023 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Webinars

Featured Podcast

Featured Whitepapers