Zavation 212-65100
by Zavation
Zavation 212-65100 is a medical device (FDA Class II; FDA product code OVD, Intervertebral Fusion Device With Integrated Fixation, Lumbar) made by Zavation, cleared under FDA 510(k) K153404 on 21 Apr 2016 and listed in FDA GUDID since 24 Jan 2018 (UDI-DI 00842166113527), 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 | Number00842166113527 | Date24 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153404 | Date21 Apr 2016 | StatusActive |
Official records
- AccessGUDID record 00842166113527
- FDA 510(k) database K153404
Across registries
- FDA 510(k) K153404 decided 21 Apr 2016 Active
- FDA GUDID UDI-DI 00842166113527 listed 24 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K153404
- Listed FDA GUDID 00842166113527
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- Withdrawn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
- 212-65100
- Primary DI / UDI-DI
- 00842166113527
- 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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