Trigen 71691166
Trigen 71691166 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K130748 on 4 Aug 2013 (1 earlier submission) and listed in FDA GUDID since 28 Sep 2015 (UDI-DI 00885556325544), 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 | Number00885556325544 | Date28 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK130748 | Date4 Aug 2013 | StatusActive |
Official records
- AccessGUDID record 00885556325544
- FDA 510(k) database K130748
- FDA 510(k) database K123055
Across registries
- FDA 510(k) K130748 decided 4 Aug 2013 Active
- FDA GUDID UDI-DI 00885556325544 listed 28 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K123055
- Cleared FDA 510(k) K130748
- Listed FDA GUDID 00885556325544
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trigen
- Generic name
- Orthopaedic stereotactic surgery system
- Model / Ref / Catalog
- 71691166
- Primary DI / UDI-DI
- 00885556325544
- FDA product code
- HRS, OLO
- GMDN term
- Orthopaedic stereotactic surgery system
- Device class
- Class II
- Regulation number
- 888.3030, 882.4560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Orthopaedic stereotactic surgery system.