LigaPASS™ System
by Medicrea International S.A.S
510(k) K261374
LigaPASS™ System is a Class II device made by Medicrea International S.A.S, cleared under FDA 510(k) K261374 on 27 May 2026, active as of 25 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK261374 | Date27 May 2026 | StatusActive |
Official records
- FDA 510(k) database K261374
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OWI
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3010
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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