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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/Polymer, Cemented
510(k) Number K142761
Device Name Corin TaperFit Hip Stem
Applicant
CORIN USA
5670 W. CYPRESS ST.
SUITE C
TAMPA,  FL  33607
Applicant Contact Diana L Nader-Martone
Correspondent
CORIN USA
5670 W. CYPRESS ST.
SUITE C
TAMPA,  FL  33607
Correspondent Contact Diana L Nader-Martone
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
JDG  
Date Received09/25/2014
Decision Date 04/03/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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