K240461
- 510(k) number
- K240461
- Device name
- OsteoSinter® EVANS and COTTON wedges and related accessories
- Applicant
- Ames Medical Prosthetic Solutions, S.A.U. ES
- Product code
- PLF — Bone Wedge
- Decision date
- 2024-12-06
- Date received
- 2024-02-16
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K240461.pdf
Official FDA record: K240461
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.