Trigen 71674077
Trigen 71674077 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K122170 on 19 Oct 2012 and listed in FDA GUDID since 13 Nov 2017 (UDI-DI 03596010560735), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03596010560735 | Date13 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122170 | Date19 Oct 2012 | StatusActive |
Official records
- AccessGUDID record 03596010560735
- FDA 510(k) database K122170
Across registries
- FDA 510(k) K122170 decided 19 Oct 2012 Active
- FDA GUDID UDI-DI 03596010560735 listed 13 Nov 2017 Listed
Recalls
-
- Terminated Z-0351-2020
LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not fully compress.
Timeline
- Cleared FDA 510(k) K122170
- Listed FDA GUDID 03596010560735
- Recall initiated FDA recalls Z-0351-2020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trigen
- Generic name
- Orthopaedic bone-reduction tool
- Model / Ref / Catalog
- 71674077
- Primary DI / UDI-DI
- 03596010560735
- 510(k) Number
- FDA product code
- HSB
- GMDN term
- Orthopaedic bone-reduction tool
- Device class
- Class II
- Regulation number
- 888.3020
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Orthopaedic bone-reduction tool.