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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 K170359
Device Name Trinity™ Dual Mobility System
Applicant
Corin USA Limited
5670 W Cypress Street Suite C
Tampa,  FL  33607
Applicant Contact Zak Akhoonjee
Correspondent
Corin USA Limited
5670 W Cypress Street Suite C
Tampa,  FL  33607
Correspondent Contact Lucinda Gerber
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received02/06/2017
Decision Date 10/31/2017
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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