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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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