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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 K083312
Device Name MINIHIP STEM
Applicant
Corin USA
10500 University Center Dr.
Suite 190
Tampa,  FL  33612
Applicant Contact ASHLEA BOWEN
Correspondent
Corin USA
10500 University Center Dr.
Suite 190
Tampa,  FL  33612
Correspondent Contact ASHLEA BOWEN
Regulation Number888.3353
Classification Product Code
LZO  
Date Received11/10/2008
Decision Date 04/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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