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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 K173880
Device Name Corin TriFit CF Hip Stem
Applicant
Corin USA Limited
12750 Citrus Park Lane
Tampa,  FL  33625
Applicant Contact Rachel King
Correspondent
Corin USA Limited
12750 Citrus Park Lane
Tampa,  FL  33625
Correspondent Contact Rachel King
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
KWL   KWY   LPH   LZO   MBL  
Date Received12/21/2017
Decision Date 04/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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