Arrow® 265168 - Cortical Bone Screw, Ø4, 5 L32
by Fournitures Hospitalieres Industrie
Arrow® 265168 - Cortical Bone Screw, Ø4, 5 L32 is a Class II device made by Fournitures Hospitalieres Industrie, cleared under FDA 510(k) K112193 on 12 Jul 2012 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 03661489651687), active as of 22 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 | Number03661489651687 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112193 | Date12 Jul 2012 | StatusActive |
Official records
- AccessGUDID record 03661489651687
- FDA 510(k) database K112193
Across registries
- FDA 510(k) K112193 decided 12 Jul 2012 Active
- FDA GUDID UDI-DI 03661489651687 listed 24 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K112193
- Listed FDA GUDID 03661489651687
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Arrow®
- Generic name
- Total reverse shoulder prosthesis
- Model / reference
- 265168 - CORTICAL BONE SCREW, Ø4, 5 L32
- Primary DI / UDI-DI
- 03661489651687
- 510(k) Number
- FDA product code
- KWT, KWS
- GMDN term
- Total reverse shoulder prosthesis
- Device class
- Class II
- Regulation number
- 888.3650, 888.3660
- GUDID distribution status
- In Commercial Distribution