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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 K082525
Device Name CORIN METAFIX FEMORAL STEM
Applicant
CORIN USA
10500 UNIVERSITY CENTER DRIVE
SUITE 190
TAMPA,  FL  33612
Applicant Contact ASHLEA BOWEN
Correspondent
CORIN USA
10500 UNIVERSITY CENTER DRIVE
SUITE 190
TAMPA,  FL  33612
Correspondent Contact ASHLEA BOWEN
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
JDI  
Date Received09/02/2008
Decision Date 02/04/2010
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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