The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Trigen Adolescent Tan.
| Device ID | K040929 |
| 510k Number | K040929 |
| Device Name: | TRIGEN ADOLESCENT TAN |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Kim Kelly |
| Correspondent | Kim Kelly SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-09 |
| Decision Date | 2004-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556662243 | K040929 | 000 |
| 00885556815274 | K040929 | 000 |
| 03596010541437 | K040929 | 000 |
| 03596010541420 | K040929 | 000 |
| 03596010541413 | K040929 | 000 |
| 03596010541406 | K040929 | 000 |
| 03596010541390 | K040929 | 000 |
| 03596010541352 | K040929 | 000 |
| 03596010541345 | K040929 | 000 |
| 03596010541338 | K040929 | 000 |
| 03596010541321 | K040929 | 000 |
| 00885556815281 | K040929 | 000 |
| 00885556815304 | K040929 | 000 |
| 00885556590508 | K040929 | 000 |
| 00885556037263 | K040929 | 000 |
| 00885556036006 | K040929 | 000 |
| 03596010541383 | K040929 | 000 |
| 03596010541376 | K040929 | 000 |
| 03596010541369 | K040929 | 000 |
| 03596010541307 | K040929 | 000 |
| 03596010541291 | K040929 | 000 |
| 03596010541284 | K040929 | 000 |
| 00885556815311 | K040929 | 000 |
| 03596010541314 | K040929 | 000 |