May FDA approved 28 orthopedic devices

2021-11-25 03:18:23 By : Mr. Hope Wang

In May, the FDA granted 510(k) approvals for multiple knee, hip, shoulder, and spine devices.

1. Link MobileLink acetabular cup system from Waldemar Link 2. Genius/Genuin total knee system from Biorad Medisys 3. Rebellion and Phantom multi-bite rongeur from Morpheus 4. Cuvis-spine from Curexo 5. BonOs Inject, pedicle screw kit and bone cement are from Ostartis putter 6. Ignite Anatomical Shoulder System by Ignite Orthopedics 7. DRPx Locking Distal Radial Plate System by Orthopedic Implant Company 8. Cap Spheres Particle Pack by Zimmer Biomet Spine 9. Wright Medical’s Dart-Fire Edge Hollow Screw System 10. Blackhawk Ti ChoiceSpine’s Cervical Spine System 11. In2Bones USA’s CoLink Sfx Implant System 12. Wright Medical’s FuseForce Flex Dynamic Compression System 13. Conformis’ Identity Imprint Knee Replacement System 14 The NuVasive Modulus of NuVasive 15 can expand the posterior lumbar spine MOD-EX PL intervertebral system. Coligne's GII spinal fixation system 16. Medtronic Sofamor Danek's Catalyst PL expandable intervertebral disc system 17. Nu's MOD-Ex XLIF intervertebral disc system Vasive 18. OrthoGold 100 from tissue regeneration technology 19. Actis DuoFix hip prosthesis from DePuy Ireland -Without collar 20. iTotal Identity cross-fixed knee replacement system from Conformis 21. Persona from Zimmer revision knee system femoral metaphysis 22. Medical screw system system from Reliance 23. GMK Spherika femoral and fixation from Medacta Tibia tray 24. LigaPass spine system from Medtronic 25. External fixation system from Orthopedic Implant 26. Legion CR porous plus HA femoral component from Smith Nephew 27. Endoskeletal TC intervertebral system from Medtronic 28. From Extremeity Medical's Axis Charcot Fixation System

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