The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Legion Cobalt Chrome Revision Knee System.
| Device ID | K060742 |
| 510k Number | K060742 |
| Device Name: | LEGION COBALT CHROME REVISION KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Jason Sells |
| Correspondent | Jason Sells SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-20 |
| Decision Date | 2006-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010580306 | K060742 | 000 |
| 03596010580429 | K060742 | 000 |
| 03596010580436 | K060742 | 000 |
| 03596010607607 | K060742 | 000 |
| 03596010608338 | K060742 | 000 |
| 03596010608345 | K060742 | 000 |
| 03596010611406 | K060742 | 000 |
| 03596010611413 | K060742 | 000 |
| 03596010611505 | K060742 | 000 |
| 03596010580412 | K060742 | 000 |
| 03596010580405 | K060742 | 000 |
| 03596010580399 | K060742 | 000 |
| 03596010580313 | K060742 | 000 |
| 03596010580320 | K060742 | 000 |
| 03596010580337 | K060742 | 000 |
| 03596010580344 | K060742 | 000 |
| 03596010580351 | K060742 | 000 |
| 03596010580368 | K060742 | 000 |
| 03596010580375 | K060742 | 000 |
| 03596010580382 | K060742 | 000 |
| 00885556029428 | K060742 | 000 |
| 00885556029442 | K060742 | 000 |
| 00885556030608 | K060742 | 000 |
| 00885556030721 | K060742 | 000 |
| 00885556030790 | K060742 | 000 |
| 00885556030943 | K060742 | 000 |
| 00885556031001 | K060742 | 000 |
| 00885556031049 | K060742 | 000 |
| 00885556031223 | K060742 | 000 |
| 00885556031292 | K060742 | 000 |
| 00885556030578 | K060742 | 000 |
| 00885556030530 | K060742 | 000 |
| 00885556030462 | K060742 | 000 |
| 00885556029930 | K060742 | 000 |
| 00885556030035 | K060742 | 000 |
| 00885556030158 | K060742 | 000 |
| 00885556030165 | K060742 | 000 |
| 00885556030257 | K060742 | 000 |
| 00885556030325 | K060742 | 000 |
| 00885556030349 | K060742 | 000 |
| 00885556030400 | K060742 | 000 |
| 00885556031391 | K060742 | 000 |