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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
Applicant
CORIN U.S.A.
10500 university center dr.,
suite 190
tampa,  FL  33612
Applicant Contact lucinda gerber
Correspondent
CORIN U.S.A.
10500 university center dr.,
suite 190
tampa,  FL  33612
Correspodent 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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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