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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 K162127
Device Name Bencox M Stem Lateralized & Bencox Mirabo Cup System
Applicant
CORENTEC CO., LTD
12, YEONGSANHONG 1-GIL, IPJANG-MYEON, SEOBUK GU
CHEONAN-SI,  KR 31056
Applicant Contact J. S. DANIEL
Correspondent
CORENTEC CO., LTD
8F CHUNGHO TOWER, 483, GANGNAM-DAERO
SEOCHO GU
SEOUL,  KR 06541
Correspondent Contact J. S. DANIEL
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWY   LZO  
Date Received08/01/2016
Decision Date 12/05/2016
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
Recalls CDRH Recalls
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