Trigen Adolescent Tan
510(k) K040929
Trigen Adolescent Tan is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K040929 on 25 May 2004, 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 | FDA 510(k)SESE | NumberK040929 | Date25 May 2004 | StatusActive |
Official records
- FDA 510(k) database K040929
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HSB
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3020
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K040929
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| TRIGEN 71645124 | 71645124 / 71645124 | 00885556037263 | — | On the market |
| TRIGEN 71645126 | 71645126 / 71645126 | 03596010541284 | — | On the market |
| TRIGEN 71645128 | 71645128 / 71645128 | 03596010541291 | — | On the market |
| TRIGEN 71645130 | 71645130 / 71645130 | 03596010541307 | — | On the market |
| TRIGEN 71645132 | 71645132 / 71645132 | 03596010541314 | — | On the market |
| TRIGEN 71645134 | 71645134 / 71645134 | 03596010541321 | — | On the market |
| TRIGEN 71645136 | 71645136 / 71645136 | 03596010541338 | — | On the market |
| TRIGEN 71645138 | 71645138 / 71645138 | 03596010541345 | — | On the market |
| TRIGEN 71645140 | 71645140 / 71645140 | 03596010541352 | — | On the market |
| TRIGEN 71646124 | 71646124 / 71646124 | 00885556036006 | — | On the market |
| TRIGEN 71646126 | 71646126 / 71646126 | 03596010541369 | — | On the market |
| TRIGEN 71646128 | 71646128 / 71646128 | 03596010541376 | — | On the market |
| TRIGEN 71646130 | 71646130 / 71646130 | 03596010541383 | — | On the market |
| TRIGEN 71646132 | 71646132 / 71646132 | 03596010541390 | — | On the market |
| TRIGEN 71646134 | 71646134 / 71646134 | 03596010541406 | — | On the market |
| TRIGEN 71646136 | 71646136 / 71646136 | 03596010541413 | — | On the market |
| TRIGEN 71646138 | 71646138 / 71646138 | 03596010541420 | — | On the market |
| TRIGEN 71646140 | 71646140 / 71646140 | 03596010541437 | — | On the market |
| Trigen XT001003-1 | XT001003-1 / XT001003-1 | 00885556590508 | — | On the market |
| TRIGEN XT001051-1 | XT001051-1 / XT001051-1 | 00885556662243 | — | On the market |
| Trigen XT001162-1 | XT001162-1 / XT001162-1 | 00885556815274 | — | On the market |
| Trigen XT001162-2 | XT001162-2 / XT001162-2 | 00885556815281 | — | On the market |
| Trigen XT001162-3 | XT001162-3 / XT001162-3 | 00885556815304 | — | On the market |
| Trigen XT001162-4 | XT001162-4 / XT001162-4 | 00885556815311 | — | On the market |