Ligapass
510(k) K132395
Ligapass is a Class II device made by Medicrea International, cleared under FDA 510(k) K132395 on 6 Dec 2013 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 03613720000280), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number03613720000280 | Date16 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE 510(k) | NumberK132395 | Date6 Dec 2013 | StatusActive |
Official records
- AccessGUDID record 03613720000280
- FDA 510(k) database K132395
Across registries
- FDA 510(k) K132395 decided 6 Dec 2013 Active
- FDA GUDID UDI-DI 03613720000280 listed 16 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K132395
- Listed FDA GUDID 03613720000280
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Internal orthopaedic fixation system, cerclage wire/cable, sterile
- Model / reference
- B08100001
- Primary DI / UDI-DI
- 03613720000280
- 510(k) Number
- FDA product code
- OWI
- GMDN term
- Internal orthopaedic fixation system, cerclage wire/cable, sterile
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3010
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
- GUDID distribution status
- Not in Commercial Distribution