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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 K142807
FOIA Releasable 510(k) K142807
Device Name ANTHEM PS Total Knee System
Applicant
Smith & Nephew, Inc.
1450 Brooks Road
Memphis,  TN  38116
Applicant Contact Samir Ibrahim
Correspondent
Smith & Nephew, Inc.
1450 Brooks Road
Memphis,  TN  38116
Correspondent Contact Samir Ibrahim
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/29/2014
Decision Date 12/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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