K251680
- 510(k) number
- K251680
- Device name
- Biosteon® Screw
- Applicant
- Biocomposites, Ltd. GB
- Product code
- MAI — Fastener, Fixation, Biodegradable, Soft Tissue
- Decision date
- 2026-02-17
- Date received
- 2025-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251680.pdf
Official FDA record: K251680
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.