Zavation 380-55110-F
by Zavation
Zavation 380-55110-F is a Class II device made by Zavation, cleared under FDA 510(k) K222614 on 5 Dec 2022 and listed in FDA GUDID since 12 Dec 2023 (UDI-DI 00842166199088), 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 | Number00842166199088 | Date12 Dec 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222614 | Date5 Dec 2022 | StatusActive |
Official records
- AccessGUDID record 00842166199088
- FDA 510(k) database K222614
Across registries
- FDA 510(k) K222614 decided 5 Dec 2022 Active
- FDA GUDID UDI-DI 00842166199088 listed 12 Dec 2023 Listed
Timeline
- Cleared FDA 510(k) K222614
- Listed FDA GUDID 00842166199088
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- Withdrawn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
- 380-55110-F
- Primary DI / UDI-DI
- 00842166199088
- 510(k) Number
- FDA product code
- NKB, KWQ
- GMDN term
- Orthopaedic bone screw (non-sliding)
- Device class
- Class II
- Regulation number
- 888.3070, 888.3060
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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