K243712
- 510(k) number
- K243712
- Device name
- WasherCap Mini Fixation System (Model 45)
- Applicant
- Abanza Tecnomed S.L ES
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2025-01-30
- Date received
- 2024-12-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243712.pdf
Official FDA record: K243712
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.