The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Genesis Ii Ps Non-modular Femoral Component.
| Device ID | K120698 |
| 510k Number | K120698 |
| Device Name: | GENESIS II PS NON-MODULAR FEMORAL COMPONENT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Xiang Zhang |
| Correspondent | Xiang Zhang SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-07 |
| Decision Date | 2012-05-18 |
| Summary: | summary |