Delta 70-05168
Delta 70-05168 is a Class II device made by Stryker Leibinger, cleared under FDA 510(k) K213777 on 4 Feb 2022 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 04546540337160), 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 | NumberK213777 | Date4 Feb 2022 | StatusActive |
| United States | GUDID listing | Number04546540337160 | Date24 Sep 2015 | StatusListed |
Official records
- AccessGUDID record 04546540337160
- FDA 510(k) database K213777
- FDA 510(k) database K993061
Across registries
- FDA 510(k) K213777 decided 4 Feb 2022 Active
- FDA GUDID UDI-DI 04546540337160 listed 24 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K993061
- Listed FDA GUDID 04546540337160
- Cleared FDA 510(k) K213777
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Delta
- Generic name
- Craniofacial fixation plate, bioabsorbable
- Model / Ref / Catalog
- 70-05168
- Primary DI / UDI-DI
- 04546540337160
- FDA product code
- MAI
- GMDN term
- Craniofacial fixation plate, bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution