Reunite Screw System 948176
Reunite Screw System 948176 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K992301 on 1 Sep 1999 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304423954), 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 | Number00880304423954 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK992301 | Date1 Sep 1999 | StatusActive |
Official records
- AccessGUDID record 00880304423954
- FDA 510(k) database K992301
Across registries
- FDA 510(k) K992301 decided 1 Sep 1999 Active
- FDA GUDID UDI-DI 00880304423954 listed 24 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K992301
- Listed FDA GUDID 00880304423954
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Reunite Screw System
- Generic name
- Bioabsorbable orthopaedic bone screw
- Model / Ref / Catalog
- 948176
- Primary DI / UDI-DI
- 00880304423954
- 510(k) Number
- FDA product code
- MAI, HWC
- GMDN term
- Bioabsorbable orthopaedic bone screw
- Device class
- Class II
- Regulation number
- 888.3030, 888.3040
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Bioabsorbable orthopaedic bone screw.