Vea AIX21000
Vea AIX21000 is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K211987 on 29 Oct 2021 and listed in FDA GUDID since 29 Jun 2022 (UDI-DI 00190376470351), active as of 23 Oct 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 | Number00190376470351 | Date29 Jun 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211987 | Date29 Oct 2021 | StatusActive |
Official records
- AccessGUDID record 00190376470351
- FDA 510(k) database K211987
Across registries
- FDA 510(k) K211987 decided 29 Oct 2021 Active
- FDA GUDID UDI-DI 00190376470351 listed 29 Jun 2022 Listed
Timeline
- Cleared FDA 510(k) K211987
- Listed FDA GUDID 00190376470351
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vea
- Generic name
- Orthopaedic/craniofacial implantation planning software
- Model / reference
- AIX21000
- Primary DI / UDI-DI
- 00190376470351
- 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.