MyPAO 12.1011
MyPAO 12.1011 is a Class II device made by Medacta International SA, cleared under FDA 510(k) K220706 on 30 May 2023 and listed in FDA GUDID since 1 Jun 2023 (UDI-DI 07630971287525), 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 | Number07630971287525 | Date1 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220706 | Date30 May 2023 | StatusActive |
Official records
- AccessGUDID record 07630971287525
- FDA 510(k) database K220706
Across registries
- FDA 510(k) K220706 decided 30 May 2023 Active
- FDA GUDID UDI-DI 07630971287525 listed 1 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K220706
- Listed FDA GUDID 07630971287525
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MyPAO
- Generic name
- Orthopaedic/craniofacial implantation planning software
- Model / reference
- 12.1011
- Primary DI / UDI-DI
- 07630971287525
- 510(k) Number
- FDA product code
- PBF
- GMDN term
- Orthopaedic/craniofacial implantation planning software
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Orthopaedic/craniofacial implantation planning software.