Clearance Summary
OsteoSinter® EVANS and COTTON wedges and related accessories received FDA 510(k) clearance under submission number K240461, sponsored by Ames Medical Prosthetic Solutions, S.A.U.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-12-06.
- Submission: K240461
- Applicant / Sponsor: Ames Medical Prosthetic Solutions, S.A.U.
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2024-12-06
Classification & Regulation
This clearance is catalogued under FDA product code PLF and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.