The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Asian Intramedullary Hip Screw Nails.
| Device ID | K050226 |
| 510k Number | K050226 |
| Device Name: | ASIAN INTRAMEDULLARY HIP SCREW NAILS |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | David Henley |
| Correspondent | David Henley SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-01 |
| Decision Date | 2005-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556039885 | K050226 | 000 |
| 00885556037393 | K050226 | 000 |
| 00885556037331 | K050226 | 000 |
| 00885556037249 | K050226 | 000 |
| 00885556037195 | K050226 | 000 |
| 00885556037157 | K050226 | 000 |
| 00885556037133 | K050226 | 000 |
| 00885556037119 | K050226 | 000 |
| 00885556037058 | K050226 | 000 |
| 00885556036914 | K050226 | 000 |
| 00885556036884 | K050226 | 000 |
| 00885556036761 | K050226 | 000 |
| 00885556036723 | K050226 | 000 |
| 00885556036709 | K050226 | 000 |
| 00885556036358 | K050226 | 000 |
| 00885556036266 | K050226 | 000 |
| 00885556037423 | K050226 | 000 |
| 00885556037454 | K050226 | 000 |
| 00885556037478 | K050226 | 000 |
| 00885556039595 | K050226 | 000 |
| 00885556039007 | K050226 | 000 |
| 00885556038796 | K050226 | 000 |
| 00885556038000 | K050226 | 000 |
| 00885556037850 | K050226 | 000 |
| 00885556037737 | K050226 | 000 |
| 00885556037652 | K050226 | 000 |
| 00885556037638 | K050226 | 000 |
| 00885556037621 | K050226 | 000 |
| 00885556037591 | K050226 | 000 |
| 00885556037584 | K050226 | 000 |
| 00885556037577 | K050226 | 000 |
| 00885556037553 | K050226 | 000 |
| 00885556037522 | K050226 | 000 |
| 00885556037508 | K050226 | 000 |
| 00885556035856 | K050226 | 000 |