K261374
- 510(k) number
- K261374
- Device name
- LigaPASS System
- Applicant
- Medicrea International S.A.S FR
- Product code
- OWI — Bone Fixation Cerclage, Sublaminar
- Decision date
- 2026-05-27
- Date received
- 2026-04-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K261374.pdf
Official FDA record: K261374
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.