The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Genesis Unicondylar Uhmwpe Articular Inserts.
| Device ID | K100197 |
| 510k Number | K100197 |
| Device Name: | GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Gino Brooks |
| Correspondent | Gino Brooks SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-22 |
| Decision Date | 2010-02-19 |
| Summary: | summary |