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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
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