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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/Polymer, Porous Uncemented
510(k) Number K120924
Device Name BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG
Applicant
CORENTEC CO., LTD
11TH CHUNGHO TOWER
748-1 BANPO 1 DONG
SEOCHO GU, SEOUL,  KR 137-040
Applicant Contact J.S. DANIEL
Correspondent
CORENTEC CO., LTD
11TH CHUNGHO TOWER
748-1 BANPO 1 DONG
SEOCHO GU, SEOUL,  KR 137-040
Correspondent Contact J.S. DANIEL
Regulation Number888.3358
Classification Product Code
LPH  
Date Received03/27/2012
Decision Date 09/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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