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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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