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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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K140881
Device Name DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS
Applicant
DEPUY (IRELAND)
LOUGHBEG
RINGASKIDDY
CO. CORK,  IE
Applicant Contact NANCY FRIDDLE
Correspondent
DEPUY (IRELAND)
700 Orthopaedic Drive
Warsaw,  IN  46581
Correspondent Contact NANCY FRIDDLE
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received04/07/2014
Decision Date 02/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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