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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
Recalls CDRH Recalls
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