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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 K153381
Device Name Corin Metafix Hip Stem
Applicant
Corin U.S.A. Limited
5670 W Cypress St., Suite C
Tampa,  FL  33607
Applicant Contact Rachel King
Correspondent
Corin U.S.A. Limited
5670 W Cypress St., Suite C
Tampa,  FL  33607
Correspondent Contact Rachel King
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KWL   KWY   MEH   OQI  
Date Received11/23/2015
Decision Date 01/21/2016
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
Recalls CDRH Recalls
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