The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Trigen Hindfoot Fusion Nail.
| Device ID | K043052 |
| 510k Number | K043052 |
| Device Name: | TRIGEN HINDFOOT FUSION NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Janet Johnson Akil |
| Correspondent | Janet Johnson Akil SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-05 |
| Decision Date | 2004-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556794654 | K043052 | 000 |
| 03596010543165 | K043052 | 000 |
| 03596010543172 | K043052 | 000 |
| 03596010543189 | K043052 | 000 |
| 03596010543196 | K043052 | 000 |
| 03596010543202 | K043052 | 000 |
| 03596010543219 | K043052 | 000 |
| 00885556776049 | K043052 | 000 |
| 00885556776056 | K043052 | 000 |
| 03596010543158 | K043052 | 000 |
| 03596010543141 | K043052 | 000 |
| 00885556886274 | K043052 | 000 |
| 00885556880524 | K043052 | 000 |
| 00885556869949 | K043052 | 000 |
| 00885556816943 | K043052 | 000 |
| 03596010542489 | K043052 | 000 |
| 03596010542496 | K043052 | 000 |
| 03596010543127 | K043052 | 000 |
| 03596010543134 | K043052 | 000 |
| 00885556058183 | K043052 | 000 |
| 00885556058213 | K043052 | 000 |
| 00885556058756 | K043052 | 000 |
| 00885556624142 | K043052 | 000 |
| 00885556633335 | K043052 | 000 |
| 00885556661543 | K043052 | 000 |
| 00885556667941 | K043052 | 000 |
| 00885556672334 | K043052 | 000 |
| 00885556710326 | K043052 | 000 |
| 00885556721469 | K043052 | 000 |
| 00885556727676 | K043052 | 000 |
| 00885556622063 | K043052 | 000 |
| 00885556060650 | K043052 | 000 |
| 00885556058893 | K043052 | 000 |
| 00885556059029 | K043052 | 000 |
| 00885556059692 | K043052 | 000 |
| 00885556059906 | K043052 | 000 |
| 00885556059975 | K043052 | 000 |
| 00885556060377 | K043052 | 000 |
| 00885556060452 | K043052 | 000 |
| 00885556060636 | K043052 | 000 |
| 00885556732489 | K043052 | 000 |