2.4mm Sternalock (Tm) 71-2623
2.4mm Sternalock (Tm) 71-2623 is a Class II device made by Biomet Microfixation, Inc, cleared under FDA 510(k) K161896 on 2 Aug 2016 (2 earlier submissions) and listed in FDA GUDID since 11 Oct 2015 (UDI-DI 00841036070489), 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 | FDA 510(k)SESE | NumberK161896 | Date2 Aug 2016 | StatusActive |
| United States | GUDID listing | Number00841036070489 | Date11 Oct 2015 | StatusListed |
Official records
- AccessGUDID record 00841036070489
- FDA 510(k) database K161896
- FDA 510(k) database K121302
- FDA 510(k) database K011076
Across registries
- FDA 510(k) K161896 decided 2 Aug 2016 Active
- FDA GUDID UDI-DI 00841036070489 listed 11 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K011076
- Cleared FDA 510(k) K121302
- Listed FDA GUDID 00841036070489
- Cleared FDA 510(k) K161896
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- 2.4mm Sternalock (Tm)
- Generic name
- Sternal fixation device
- Model / Ref / Catalog
- 71-2623
- Primary DI / UDI-DI
- 00841036070489
- FDA product code
- HRS
- GMDN term
- Sternal fixation device
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization