The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Knee Fusion Nail.
| Device ID | K050938 |
| 510k Number | K050938 |
| Device Name: | KNEE FUSION NAIL |
| Classification | Nail, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Laurie Jordan |
| Correspondent | Laurie Jordan SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-14 |
| Decision Date | 2005-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556719947 | K050938 | 000 |
| 03596010609502 | K050938 | 000 |
| 03596010609519 | K050938 | 000 |
| 03596010609526 | K050938 | 000 |
| 03596010609533 | K050938 | 000 |
| 03596010609540 | K050938 | 000 |
| 03596010609557 | K050938 | 000 |
| 03596010609564 | K050938 | 000 |
| 03596010609571 | K050938 | 000 |
| 03596010609496 | K050938 | 000 |
| 03596010609489 | K050938 | 000 |
| 03596010609403 | K050938 | 000 |
| 03596010609410 | K050938 | 000 |
| 03596010609427 | K050938 | 000 |
| 03596010609434 | K050938 | 000 |
| 03596010609441 | K050938 | 000 |
| 03596010609458 | K050938 | 000 |
| 03596010609465 | K050938 | 000 |
| 03596010609472 | K050938 | 000 |
| 03596010609588 | K050938 | 000 |
| 03596010609595 | K050938 | 000 |
| 03596010609748 | K050938 | 000 |
| 00885556885468 | K050938 | 000 |
| 00885556808047 | K050938 | 000 |
| 00885556742211 | K050938 | 000 |
| 00885556603093 | K050938 | 000 |
| 00885556631942 | K050938 | 000 |
| 00885556662502 | K050938 | 000 |
| 00885556674222 | K050938 | 000 |
| 03596010609694 | K050938 | 000 |
| 03596010609687 | K050938 | 000 |
| 03596010609601 | K050938 | 000 |
| 03596010609618 | K050938 | 000 |
| 03596010609625 | K050938 | 000 |
| 03596010609632 | K050938 | 000 |
| 03596010609649 | K050938 | 000 |
| 03596010609656 | K050938 | 000 |
| 03596010609663 | K050938 | 000 |
| 03596010609670 | K050938 | 000 |
| 03596010609397 | K050938 | 000 |