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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/ceramic/polymer, cemented or non-porous, uncemented
510(k) Number K121011
Device Name AMISTEM AND QUADRA - LINE EXTENSION
Original Applicant
MEDACTA INTERNATIONAL
4725 calle quetzal, unit b
camarillo,  CA  93012
Original Contact adam gross
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received04/03/2012
Decision Date 06/08/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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