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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K151118
Device Name Smith and Nephew Legion Hinge Knee System
Applicant
Smith & Nephew
7135 Goodlett Farms Pkwy.
Memphis,  TN  38016
Applicant Contact ALLISON CHAN
Correspondent
Smith & Nephew
7135 Goodlett Farms Pkwy.
Memphis,  TN  38016
Correspondent Contact ALLISON CHAN
Regulation Number888.3510
Classification Product Code
KRO  
Date Received04/27/2015
Decision Date 07/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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