K253867
- 510(k) number
- K253867
- Device name
- FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit
- Applicant
- ZuriMED Technologies AG CH
- Product code
- OWX — Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinfo
- Decision date
- 2026-01-02
- Date received
- 2025-12-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253867.pdf
Official FDA record: K253867
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.