LigaPASS System— 510(k) K261374
Substantially EquivalentMedicrea International S.A.S
FDA 510(k) clearance K261374 for LigaPASS System, Substantially Equivalent on 2026-05-27. Applicant: Medicrea International S.A.S. Device class: 2.
Summary
Medicrea International's LigaPASS System is filed under OWI, sublaminar bone fixation cerclage.
Class II, 21 CFR 888.3010. Orthopedic is both the classification panel and the review panel, and it came in as a Special 510(k).
Medicrea filed from Rillieux-La-Pape, France. The decision came 30 calendar days after receipt (April 27 to May 27, 2026).
Clearance details
- Applicant
- Medicrea International S.A.S
- Product code
- Product code OWI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3010
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rillieux-La-Pape, FR
Recent devices under product code OWI
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