The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew, Inc. Total Knee System Instrumentation.
Device ID | K121393 |
510k Number | K121393 |
Device Name: | SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION |
Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Gino Rouss |
Correspondent | Gino Rouss SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | MBH |
Subsequent Product Code | HRY |
Subsequent Product Code | HSX |
Subsequent Product Code | JWH |
Subsequent Product Code | KRO |
Subsequent Product Code | KRQ |
Subsequent Product Code | KRR |
Subsequent Product Code | NPJ |
CFR Regulation Number | 888.3565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-05-09 |
Decision Date | 2012-08-07 |
Summary: | summary |