Ezloc 904778
Ezloc 904778 is a Class II device made by Biomet Sports Medicine, cleared under FDA 510(k) K053461 on 3 Feb 2006 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304460447), 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 | Number00880304460447 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK053461 | Date3 Feb 2006 | StatusActive |
Official records
- AccessGUDID record 00880304460447
- FDA 510(k) database K053461
Across registries
- FDA 510(k) K053461 decided 3 Feb 2006 Active
- FDA GUDID UDI-DI 00880304460447 listed 24 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K053461
- Listed FDA GUDID 00880304460447
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ezloc
- Generic name
- Bone awl, reusable
- Model / Ref / Catalog
- 904778
- Primary DI / UDI-DI
- 00880304460447
- 510(k) Number
- FDA product code
- HWC, MBI
- GMDN term
- Bone awl, reusable
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
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