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 |