The following data is part of a premarket notification filed by Smith & Nephew, Inc with the FDA for Journey Ii Xr Knee Instrument.
| Device ID | K200227 |
| 510k Number | K200227 |
| Device Name: | Journey II XR Knee Instrument |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Smith & Nephew, Inc 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Meenakshi Gupta |
| Correspondent | Brad Sheals Smith & Nephew, Inc 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-30 |
| Decision Date | 2020-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556744468 | K200227 | 000 |
| 00885556744451 | K200227 | 000 |
| 00885556744444 | K200227 | 000 |
| 00885556744437 | K200227 | 000 |