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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 K121439
Device Name METAFIX FEMORAL HIP STEM SIZE 1
Original Applicant
CORIN U.S.A.
10500 university center dr.,
suite 190
tampa,  FL  33612
Original Contact lucinda gerber
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWL   KWY  
Date Received05/15/2012
Decision Date 09/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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