K254176
- 510(k) number
- K254176
- Device name
- SINEFIX
- Applicant
- BAAT Medical Products B.V. NL
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2026-03-16
- Date received
- 2025-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K254176.pdf
Official FDA record: K254176
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.