Zavation Trial 8718-212
by Zavation
Zavation Trial 8718-212 is a Class II device made by Zavation, cleared under FDA 510(k) K162496 on 4 May 2017 and listed in FDA GUDID since 14 May 2026 (UDI-DI 00197157077938), 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 | Number00197157077938 | Date14 May 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162496 | Date4 May 2017 | StatusActive |
Official records
- AccessGUDID record 00197157077938
- FDA 510(k) database K162496
Across registries
- FDA 510(k) K162496 decided 4 May 2017 Active
- FDA GUDID UDI-DI 00197157077938 listed 14 May 2026 Listed
Timeline
- Cleared FDA 510(k) K162496
- Listed FDA GUDID 00197157077938
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Zavation Trial
- Generic name
- Internal spinal fixation force sensor trial
- Model / reference
- 8718-212
- Primary DI / UDI-DI
- 00197157077938
- 510(k) Number
- FDA product code
- MAX
- GMDN term
- Internal spinal fixation force sensor trial
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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