8 orthopedic FDA nods in Q1: Zimmer Biomet, Nevro and more


Becker's reported on eight spine and orthopedic devices earning approvals and clearances from the FDA in the first quarter of 2024.

1. SurGenTec's OsteoFlo hydroputty synthetic bone graft earned 510(k) clearance from the FDA.

2. Ortho Development earned FDA 510(k) clearance for its Trivecta hip system.

3. Bioretec earned the FDA's breakthrough device designation for its RemeOs spinal interbody cage.

4. Woven Orthopedics earned its second FDA 510(k) clearance for the Ogmed implantable sleeve.

5. Nevro earned FDA 510(k) clearance to use its sacroiliac joint fixation system without having to include a lateral screw.

6. Zimmer Biomet earned FDA clearance for the Rosa Shoulder robot.

7. ClearPoint Neuro earned FDA 510(k) clearance for its SmartFrame OR stereotactic system.

8. Providence Medical Technology earned FDA clearance for its Cavux FFS-LX lumbar facet fixation system.

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