Mpact Dm Liner Converter
510(k) K131458
Mpact Dm Liner Converter is a Class II device made by Medacta International, cleared under FDA 510(k) K131458 on 1 Oct 2013, active 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 | FDA 510(k)SESE | NumberK131458 | Date1 Oct 2013 | StatusActive |
Official records
- FDA 510(k) database K131458
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LZO
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3353
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K131458
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Double Mobility Liner 01.26.2244M | 01.26.2244M | 07630030806797 | — | On the market |
| Double Mobility Liner 01.26.2244MHC | 01.26.2244MHC | 07630030806803 | — | On the market |
| Mpact DM Converter 01.32.3641MC | 01.32.3641MC | 07630030812095 | — | On the market |
| Mpact DM Converter 01.32.3844MC | 01.32.3844MC | 07630030812200 | — | On the market |
| Mpact DM Converter 01.32.4248MC | 01.32.4248MC | 07630030812323 | — | On the market |
| Mpact DM Converter 01.32.4452MC | 01.32.4452MC | 07630030812330 | — | On the market |
| Mpact DM Converter 01.32.4856MC | 01.32.4856MC | 07630030812347 | — | On the market |
| Mpact DM Converter 01.32.5260MC | 01.32.5260MC | 07630030812354 | — | On the market |