The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Journey Ii Unicompartmental Knee System.
| Device ID | K191211 |
| 510k Number | K191211 |
| Device Name: | JOURNEY II Unicompartmental Knee System |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Meenakshi Gupta |
| Correspondent | Meenakshi Gupta Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | HSX |
| Subsequent Product Code | KRR |
| Subsequent Product Code | NPJ |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-06 |
| Decision Date | 2019-07-25 |
| Summary: | summary |