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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 K152084
Device Name Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug
Applicant
Corentec Co., Ltd.
12, Yeongsanhong 1-Gil, Ipjang-Myeon,
Cheonan-Si,  KR 331-822
Applicant Contact J S Daniel
Correspondent
Corentec Co., Ltd.
8f Chungho Tower, 483, Gangnam-Daero
Seocho Gu, Seoul,  KR 137-040
Correspondent Contact J S DANIEL
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWY   LZO  
Date Received07/27/2015
Decision Date 04/29/2016
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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