MyHip bone model 5.9040
MyHip bone model 5.9040 is a Class II device made by Medacta International SA, cleared under FDA 510(k) K221725 on 20 Jan 2023 and listed in FDA GUDID since 23 Jan 2023 (UDI-DI 07630030855825), 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 | GUDID listing | Number07630030855825 | Date23 Jan 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK221725 | Date20 Jan 2023 | StatusActive |
Official records
- AccessGUDID record 07630030855825
- FDA 510(k) database K221725
Across registries
- FDA 510(k) K221725 decided 20 Jan 2023 Active
- FDA GUDID UDI-DI 07630030855825 listed 23 Jan 2023 Listed
Timeline
- Cleared FDA 510(k) K221725
- Listed FDA GUDID 07630030855825
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MyHip bone model
- Generic name
- Orthopaedic/craniofacial implantation planning software
- Model / reference
- 5.9040
- Primary DI / UDI-DI
- 07630030855825
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Orthopaedic/craniofacial implantation planning software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Orthopaedic/craniofacial implantation planning software.