413.580
by Synthes
413.580 (413580) 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 20887587048823), 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 | Number20887587048823 | Date14 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093772 | Date29 Mar 2010 | StatusActive |
Official records
- AccessGUDID record 20887587048823
- FDA 510(k) database K093772
- FDA 510(k) database K010943
Across registries
- FDA 510(k) K093772 decided 29 Mar 2010 Active
- FDA GUDID UDI-DI 20887587048823 listed 14 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K010943
- Cleared FDA 510(k) K093772
- Listed FDA GUDID 20887587048823
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Sternal fixation device
- Model / Ref / Catalog
- 413.580, 413580
- Primary DI / UDI-DI
- 20887587048823
- FDA product code
- HRS, JDQ, HWC
- GMDN term
- Sternal fixation device
- Device class
- Class II
- Regulation number
- 888.3030, 888.3010, 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization