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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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K153772
Device Name Corin TriFit TS Hip
Applicant
Corin U.S.A. Limited
5670 W Cypress St., Suite C
Tampa,  FL  33607
Applicant Contact Diana L. Nader-Martone
Correspondent
Corin U.S.A. Limited
5670 W Cypress St., Suite C
Tampa,  FL  33607
Correspondent Contact Diana L. Nader-Martone
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
KWL   KWY   LZO  
Date Received12/31/2015
Decision Date 03/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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