K250238
- 510(k) number
- K250238
- Device name
- WasherCap Fixation System
- Applicant
- Abanza Tecnomed S.L ES
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2025-02-25
- Date received
- 2025-01-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K250238.pdf
Official FDA record: K250238
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.