K253618
- 510(k) number
- K253618
- Device name
- QuadLock Fixation System
- Applicant
- Abanza Tecnomed S.L ES
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2026-01-06
- Date received
- 2025-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K253618.pdf
Official FDA record: K253618
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.