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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
510(k) Number K111481
Device Name CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS
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
Correspondent Contact LUCINDA GERBER
Regulation Number888.3353
Classification Product Code
OQI  
Subsequent Product Codes
LZO   MEH  
Date Received05/27/2011
Decision Date 02/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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