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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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