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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 K112115
Device Name MECTACER BIOLOX(R) DELTA FEMORAL HEADS
Original Applicant
MEDACTA INTERNATIONAL
4725 calle quetzal, unit b
camarillo,  CA  93012
Original Contact adam gross
Regulation Number888.3353
Classification Product Code
LZO  
Date Received07/25/2011
Decision Date 10/07/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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