MyHip bone model 5.9030
MyHip bone model 5.9030 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) 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 07630030855818), 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 | Number07630030855818 | Date23 Jan 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK221725 | Date20 Jan 2023 | StatusActive |
Official records
- AccessGUDID record 07630030855818
- FDA 510(k) database K221725
Across registries
- FDA 510(k) K221725 decided 20 Jan 2023 Active
- FDA GUDID UDI-DI 07630030855818 listed 23 Jan 2023 Listed
Timeline
- Cleared FDA 510(k) K221725
- Listed FDA GUDID 07630030855818
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- Withdrawn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
- 5.9030
- Primary DI / UDI-DI
- 07630030855818
- 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.