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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 K120362
Device Name METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY
Original Applicant
CORIN U.S.A.
10500 university center dr.,
suite 190
tampa,  FL  33612
Original Contact lucinda gerber, ba (hons)
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWL   KWY  
Date Received02/06/2012
Decision Date 05/04/2012
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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