The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Legion Knee System.
| Device ID | K180334 |
| 510k Number | K180334 |
| Device Name: | LEGION Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Smith & Nephew, Inc. 1450 Brooks Rd. Memphis, TN 38116 |
| Contact | Michael Scott |
| Correspondent | Michael Scott 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 | 2018-02-06 |
| Decision Date | 2018-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556538388 | K180334 | 000 |
| 00885556538753 | K180334 | 000 |
| 00885556538760 | K180334 | 000 |
| 00885556538777 | K180334 | 000 |
| 00885556538432 | K180334 | 000 |
| 00885556538449 | K180334 | 000 |
| 00885556538456 | K180334 | 000 |
| 00885556538463 | K180334 | 000 |
| 00885556538470 | K180334 | 000 |
| 00885556538746 | K180334 | 000 |
| 00885556538739 | K180334 | 000 |
| 00885556538395 | K180334 | 000 |
| 00885556538661 | K180334 | 000 |
| 00885556538678 | K180334 | 000 |
| 00885556538685 | K180334 | 000 |
| 00885556538692 | K180334 | 000 |
| 00885556538708 | K180334 | 000 |
| 00885556538715 | K180334 | 000 |
| 00885556538722 | K180334 | 000 |
| 00885556538487 | K180334 | 000 |
| 00885556538494 | K180334 | 000 |
| 00885556538647 | K180334 | 000 |
| 00885556538654 | K180334 | 000 |
| 00885556538609 | K180334 | 000 |
| 00885556538333 | K180334 | 000 |
| 00885556538340 | K180334 | 000 |
| 00885556538357 | K180334 | 000 |
| 00885556538364 | K180334 | 000 |
| 00885556538371 | K180334 | 000 |
| 00885556538630 | K180334 | 000 |
| 00885556538623 | K180334 | 000 |
| 00885556538500 | K180334 | 000 |
| 00885556538517 | K180334 | 000 |
| 00885556538524 | K180334 | 000 |
| 00885556538531 | K180334 | 000 |
| 00885556538579 | K180334 | 000 |
| 00885556538586 | K180334 | 000 |
| 00885556538593 | K180334 | 000 |
| 00885556538616 | K180334 | 000 |
| 00885556538425 | K180334 | 000 |