Zavation 860-30-23
by Zavation
Zavation 860-30-23 is a Class II device made by Zavation, cleared under FDA 510(k) K230731 on 14 Jun 2023 and listed in FDA GUDID since 5 Jan 2024 (UDI-DI 00197157000264), 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 | Number00197157000264 | Date5 Jan 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK230731 | Date14 Jun 2023 | StatusActive |
Official records
- AccessGUDID record 00197157000264
- FDA 510(k) database K230731
Across registries
- FDA 510(k) K230731 decided 14 Jun 2023 Active
- FDA GUDID UDI-DI 00197157000264 listed 5 Jan 2024 Listed
Timeline
- Cleared FDA 510(k) K230731
- Listed FDA GUDID 00197157000264
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Zavation
- Generic name
- Spinal fixation plate, non-bioabsorbable
- Model / reference
- 860-30-23
- Description
- VARISYNC® ALIF RECESSED PLATE -23MM X 30°
- Primary DI / UDI-DI
- 00197157000264
- 510(k) Number
- FDA product code
- OVD
- GMDN term
- Spinal fixation plate, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization