Mpact Acetabular System 01.32.062DH
Mpact Acetabular System 01.32.062DH is a Class II device made by Medacta International SA, cleared under FDA 510(k) K250450 on 19 Sep 2025 (1 earlier submission) and listed in FDA GUDID since 18 Nov 2014 (UDI-DI 07630030810503), active as of 12 Nov 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 | NumberK250450 | Date19 Sep 2025 | StatusActive |
| United States | GUDID listing | Number07630030810503 | Date18 Nov 2014 | StatusListed |
Official records
- AccessGUDID record 07630030810503
- FDA 510(k) database K250450
- FDA 510(k) database K103721
Across registries
- FDA 510(k) K250450 decided 19 Sep 2025 Active
- FDA GUDID UDI-DI 07630030810503 listed 18 Nov 2014 Listed
Timeline
- Cleared FDA 510(k) K103721
- Listed FDA GUDID 07630030810503
- Cleared FDA 510(k) K250450
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mpact Acetabular System
- Generic name
- Acetabular shell
- Model / reference
- 01.32.062DH
- Primary DI / UDI-DI
- 07630030810503
- FDA product code
- LZO, LPH
- GMDN term
- Acetabular shell
- Device class
- Class II
- Regulation number
- 888.3353, 888.3358
- GUDID distribution status
- In Commercial Distribution
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