The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew, Inc. Hip System Instrumentation.
| Device ID | K123598 |
| 510k Number | K123598 |
| Device Name: | SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Bradley Heil |
| Correspondent | Bradley Heil SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | JDI |
| Subsequent Product Code | JDG |
| Subsequent Product Code | JDJ |
| Subsequent Product Code | JDQ |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | LZY |
| Subsequent Product Code | MBL |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-21 |
| Decision Date | 2013-06-28 |
| Summary: | summary |