Trigen 71632001
Trigen 71632001 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K243608 on 12 Jun 2025 (1 earlier submission) and listed in FDA GUDID since 30 Aug 2015 (UDI-DI 03596010478467), active as of 23 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK243608 | Date12 Jun 2025 | StatusActive |
| United States | GUDID listing | Number03596010478467 | Date30 Aug 2015 | StatusListed |
Official records
- AccessGUDID record 03596010478467
- FDA 510(k) database K243608
- FDA 510(k) database K981529
Across registries
- FDA 510(k) K243608 decided 12 Jun 2025 Active
- FDA GUDID UDI-DI 03596010478467 listed 30 Aug 2015 Listed
Recalls
-
- Terminated Z-0944-2013
- Terminated Z-0943-2013
75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.
Timeline
- Cleared FDA 510(k) K981529
- Recall initiated FDA recalls Z-0944-2013
- Recall initiated FDA recalls Z-0943-2013
- Listed FDA GUDID 03596010478467
- Cleared FDA 510(k) K243608
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trigen
- Generic name
- Femur intramedullary nail
- Model / Ref / Catalog
- 71632001
- Primary DI / UDI-DI
- 03596010478467
- FDA product code
- JDS, HSB
- GMDN term
- Femur intramedullary nail
- Device class
- Class II
- Regulation number
- 888.3030, 888.3020
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional