Sternalock 360 System 74-0012
Sternalock 360 System 74-0012 is a Class II device made by Biomet Microfixation, Inc, cleared under FDA 510(k) K163007 on 23 Nov 2016 (1 earlier submission) and listed in FDA GUDID since 17 Nov 2015 (UDI-DI 00841036190217), 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 | NumberK163007 | Date23 Nov 2016 | StatusActive |
| United States | GUDID listing | Number00841036190217 | Date17 Nov 2015 | StatusListed |
Official records
- AccessGUDID record 00841036190217
- FDA 510(k) database K163007
- FDA 510(k) database K151019
Across registries
- FDA 510(k) K163007 decided 23 Nov 2016 Active
- FDA GUDID UDI-DI 00841036190217 listed 17 Nov 2015 Listed
Timeline
- Cleared FDA 510(k) K151019
- Listed FDA GUDID 00841036190217
- Cleared FDA 510(k) K163007
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sternalock 360 System
- Generic name
- Sternal fixation device
- Model / Ref / Catalog
- 74-0012
- Primary DI / UDI-DI
- 00841036190217
- FDA product code
- HRS
- GMDN term
- Sternal fixation device
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional