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.

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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.

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

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Wednesday, July 29
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Presenters: Joe Ganley, athenahealthJeffrey Flynn, CASC, Gramercy Surgery CenterBryan Tsao, Access Center, Loma Linda University HealthJason Zepeda, Northridge Hospital Medical Center, CommonSpirit HealthGreg DeConciliis, PA-C, CASC, Boston Out­Patient Surgical Suites

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