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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 K153725
Device Name Corin TaperFit Hip Stem
Applicant
CORIN USA LIMITED
5670 W. CYPRESS ST.
SUITE C
TAMPA,  FL  33607
Applicant Contact DIANA L. NADER-MARTONE
Correspondent
CORIN USA LIMITED
5670 W. CYPRESS ST.
SUITE C
TAMPA,  FL  33607
Correspondent Contact DIANA L. NADER-MARTONE
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
JDG   KWY  
Date Received12/28/2015
Decision Date 03/25/2016
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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