04.501.112S
by Synthes
04.501.112S (04501112S) is a Class II device made by Synthes, cleared under FDA 510(k) K093772 on 29 Mar 2010 (1 earlier submission) and listed in FDA GUDID since 14 Sep 2015 (UDI-DI 10887587017389), 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 | Number10887587017389 | Date14 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093772 | Date29 Mar 2010 | StatusActive |
Official records
- AccessGUDID record 10887587017389
- FDA 510(k) database K093772
- FDA 510(k) database K081700
Across registries
- FDA 510(k) K093772 decided 29 Mar 2010 Active
- FDA GUDID UDI-DI 10887587017389 listed 14 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K081700
- Cleared FDA 510(k) K093772
- Listed FDA GUDID 10887587017389
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Orthopaedic bone screw (non-sliding)
- Model / Ref / Catalog
- 04.501.112S, 04501112S
- Primary DI / UDI-DI
- 10887587017389
- FDA product code
- HWC, HRS
- GMDN term
- Orthopaedic bone screw (non-sliding)
- Device class
- Class II
- Regulation number
- 888.3040, 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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