The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Anthem Cr Total Knee System.
| Device ID | K170648 |
| 510k Number | K170648 |
| Device Name: | ANTHEM CR Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Thomas Fearnley |
| Correspondent | Thomas Fearnley 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 | 2017-03-03 |
| Decision Date | 2017-05-11 |
| Summary: | summary |