The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Genesis Ii Xlpe Resurfacing Patellar Components.
| Device ID | K150241 |
| 510k Number | K150241 |
| Device Name: | Genesis II XLPE Resurfacing Patellar Components |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkways Cordova, TN 38018 |
| Contact | Allison Chan |
| Correspondent | Allison Chan Smith & Nephew, Inc. 7135 Goodlett Farms Parkways Cordova, TN 38018 |
| Product Code | JWH |
| Subsequent Product Code | KRO |
| Subsequent Product Code | KRR |
| Subsequent Product Code | MBH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-02 |
| Decision Date | 2015-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556463345 | K150241 | 000 |
| 00885556867426 | K150241 | 000 |
| 00885556765494 | K150241 | 000 |
| 00885556462942 | K150241 | 000 |
| 00885556462997 | K150241 | 000 |
| 00885556463048 | K150241 | 000 |
| 00885556463093 | K150241 | 000 |
| 00885556463147 | K150241 | 000 |
| 00885556463192 | K150241 | 000 |
| 00885556463246 | K150241 | 000 |
| 00885556463291 | K150241 | 000 |
| 00885556887790 | K150241 | 000 |