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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 USA Limited
5670 W. Cypress St., Suite C
Tampa,  FL  33607
Applicant Contact Rachel King
Correspondent
Corin USA 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
Recalls CDRH Recalls
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