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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, SA
18 BIRDIE LANE
NORFOLK,  MA  02056
Applicant Contact PAMELA J WEAGRAFF
Correspondent
MEDACTA INTERNATIONAL, SA
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
Recalls CDRH Recalls
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