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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, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K160738
Device Name ZUK Select Knee System
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Cordova,  TN  38016
Applicant Contact BRAD SHEALS
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Cordova,  TN  38016
Correspondent Contact BRAD SHEALS
Regulation Number888.3520
Classification Product Code
HSX  
Subsequent Product Codes
KRR   NPJ   OIY  
Date Received03/17/2016
Decision Date 06/15/2016
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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