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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K072857
Device Name TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT
Applicant
Medacta International S.A.
18 Birdie Lane
Norfolk,  MA  02056
Applicant Contact PAMELA J WEAGRAFF
Correspondent
Medacta International S.A.
18 Birdie Lane
Norfolk,  MA  02056
Correspondent Contact PAMELA J WEAGRAFF
Regulation Number888.3350
Classification Product Code
JDI  
Date Received10/05/2007
Decision Date 02/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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