The following data is part of a premarket notification filed by Smith & Nephew with the FDA for Smith And Nephew Legion Hinge Knee System.
Device ID | K151118 |
510k Number | K151118 |
Device Name: | Smith And Nephew Legion Hinge Knee System |
Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
Applicant | SMITH & NEPHEW 7135 GOODLETT FARMS PARKWAY Cordova, TN 38016 |
Contact | Allison Chan |
Correspondent | Allison Chan SMITH & NEPHEW 7135 GOODLETT FARMS PARKWAY Cordova, TN 38016 |
Product Code | KRO |
CFR Regulation Number | 888.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-04-27 |
Decision Date | 2015-07-28 |
Summary: | summary |