The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Zuk Select Knee System.
| Device ID | K160738 |
| 510k Number | K160738 |
| Device Name: | ZUK Select Knee System |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 7135 GOODLETT FARMS PARKWAY Cordova, TN 38016 |
| Contact | Brad Sheals |
| Correspondent | Brad Sheals SMITH & NEPHEW, INC. 7135 GOODLETT FARMS PARKWAY Cordova, TN 38016 |
| Product Code | HSX |
| Subsequent Product Code | KRR |
| Subsequent Product Code | NPJ |
| Subsequent Product Code | OIY |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-17 |
| Decision Date | 2016-06-15 |
| Summary: | summary |