Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K190085
Journey II Unicompartmental Knee System · Smith & Nephew, Inc. · decided 2019-02-11 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| JOURNEY | 74035828 | Smith & Nephew, Inc. | HSX | 00885556690390 |
| JOURNEY | 74026280 | Smith & Nephew, Inc. | HSX | 00885556680919 |
| JOURNEY | 74026262 | Smith & Nephew, Inc. | HSX | 00885556680667 |
| JOURNEY | 74036022 | Smith & Nephew, Inc. | HSX | 00885556691458 |
| JOURNEY II UNI | 74035875 | Smith & Nephew, Inc. | HSX | 00885556690802 |
| JOURNEY | 74035897 | Smith & Nephew, Inc. | HSX | 00885556690970 |
| JOURNEY | 74026169 | Smith & Nephew, Inc. | HSX | 00885556677148 |
| JOURNEY | 74035923 | Smith & Nephew, Inc. | HSX | 00885556691076 |
| JOURNEY | 74035841 | Smith & Nephew, Inc. | HSX | 00885556690529 |
| JOURNEY | 74026022 | Smith & Nephew, Inc. | HSX | 00885556675052 |
| JOURNEY | 74036080 | Smith & Nephew, Inc. | HSX | 00885556691908 |
| JOURNEY | 74026180 | Smith & Nephew, Inc. | HSX | 00885556677223 |
| JOURNEY | 74026131 | Smith & Nephew, Inc. | HSX | 00885556676844 |
| JOURNEY | 74036061 | Smith & Nephew, Inc. | HSX | 00885556691755 |
| JOURNEY | 74026161 | Smith & Nephew, Inc. | HSX | 00885556677094 |
| JOURNEY II UNI | 74036043 | Smith & Nephew, Inc. | HSX | 00885556691618 |
| JOURNEY | 74036024 | Smith & Nephew, Inc. | HSX | 00885556691472 |
| JOURNEY | 74035925 | Smith & Nephew, Inc. | HSX | 00885556691083 |
| JOURNEY II UNI | 74035877 | Smith & Nephew, Inc. | HSX | 00885556690819 |
| JOURNEY | 74035857 | Smith & Nephew, Inc. | HSX | 00885556690680 |
| JOURNEY | 74035836 | Smith & Nephew, Inc. | HSX | 00885556690475 |
| JOURNEY II UNI | 74026025 | Smith & Nephew, Inc. | HSX | 00885556675786 |
| JOURNEY | 74035927 | Smith & Nephew, Inc. | HSX | 00885556691090 |
| JOURNEY II UNI | 74035873 | Smith & Nephew, Inc. | HSX | 00885556690796 |
| JOURNEY | 74026271 | Smith & Nephew, Inc. | HSX | 00885556680780 |