Zavation 212-8575
by Zavation
Zavation 212-8575 is a Class II device made by Zavation, cleared under FDA 510(k) K153404 on 21 Apr 2016 and listed in FDA GUDID since 25 Jan 2018 (UDI-DI 00842166113954), 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 | Number00842166113954 | Date25 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153404 | Date21 Apr 2016 | StatusActive |
Official records
- AccessGUDID record 00842166113954
- FDA 510(k) database K153404
Across registries
- FDA 510(k) K153404 decided 21 Apr 2016 Active
- FDA GUDID UDI-DI 00842166113954 listed 25 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K153404
- Listed FDA GUDID 00842166113954
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Zavation
- Generic name
- Orthopaedic bone screw (non-sliding)
- Model / reference
- 212-8575
- Primary DI / UDI-DI
- 00842166113954
- 510(k) Number
- FDA product code
- OVD
- GMDN term
- Orthopaedic bone screw (non-sliding)
- 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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