The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Legion Narrow Oxinium Cruciate Retaining And Posterior Stabilized Fenoral Components.
| Device ID | K112941 |
| 510k Number | K112941 |
| Device Name: | LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | David Henley |
| Correspondent | David Henley SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-04 |
| Decision Date | 2011-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556234655 | K112941 | 000 |
| 00885556234006 | K112941 | 000 |
| 00885556233955 | K112941 | 000 |
| 00885556233900 | K112941 | 000 |
| 00885556233856 | K112941 | 000 |
| 00885556233801 | K112941 | 000 |
| 00885556233757 | K112941 | 000 |
| 00885556233702 | K112941 | 000 |
| 00885556233603 | K112941 | 000 |
| 00885556233559 | K112941 | 000 |
| 00885556233504 | K112941 | 000 |
| 00885556234051 | K112941 | 000 |
| 00885556234105 | K112941 | 000 |
| 00885556234600 | K112941 | 000 |
| 00885556234556 | K112941 | 000 |
| 00885556234501 | K112941 | 000 |
| 00885556234457 | K112941 | 000 |
| 00885556234402 | K112941 | 000 |
| 00885556234358 | K112941 | 000 |
| 00885556234303 | K112941 | 000 |
| 00885556234259 | K112941 | 000 |
| 00885556234204 | K112941 | 000 |
| 00885556234150 | K112941 | 000 |
| 00885556233450 | K112941 | 000 |