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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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K150241
Device Name Genesis II XLPE Resurfacing Patellar Components
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Parkways
cordova,  TN  38018
Applicant Contact allison chan
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Parkways
cordova,  TN  38018
Correspondent Contact allison chan
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
KRO   KRR   MBH  
Date Received02/02/2015
Decision Date 10/27/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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