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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 K111046
Device Name CORIN MINIHIP FEMORAL STEM
Applicant
CORIN USA
10500 UNIVERSITY CENTER DRIVE
SUITE 190
TAMPA,  FL  33612
Applicant Contact LUCINDA GERBER
Correspondent
CORIN USA
10500 UNIVERSITY CENTER DRIVE
SUITE 190
TAMPA,  FL  33612
Correspondent Contact LUCINDA GERBER
Regulation Number888.3353
Classification Product Code
LZO  
Date Received04/15/2011
Decision Date 06/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
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