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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 PARKWAY
cordova,  TN  38016
Applicant Contact brad sheals
Correspondent
SMITH & NEPHEW, INC.
7135 GOODLETT FARMS PARKWAY
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
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