Zavation 250-9004-1416
by Zavation
Zavation 250-9004-1416 is a Class II device made by Zavation, cleared under FDA 510(k) K180673 on 13 Jul 2018 and listed in FDA GUDID since 27 Jul 2018 (UDI-DI 00842166122543), active as of 22 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 | Number00842166122543 | Date27 Jul 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180673 | Date13 Jul 2018 | StatusActive |
Official records
- AccessGUDID record 00842166122543
- FDA 510(k) database K180673
Across registries
- FDA 510(k) K180673 decided 13 Jul 2018 Active
- FDA GUDID UDI-DI 00842166122543 listed 27 Jul 2018 Listed
Timeline
- Cleared FDA 510(k) K180673
- Listed FDA GUDID 00842166122543
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Zavation
- Generic name
- Vertebral body prosthesis, non-sterile
- Model / reference
- 250-9004-1416
- Primary DI / UDI-DI
- 00842166122543
- 510(k) Number
- FDA product code
- PLR, MQP
- GMDN term
- Vertebral body prosthesis, non-sterile
- Device class
- Class II
- Regulation number
- 888.3060
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization