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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 K223223
Device Name BENCOX Mirabo Z Cup Cortinium
Applicant
Corentec Co., Ltd.
12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu,
Cheonan-si, Chungcheongnam-do
Cheonan-si,  KR 31056
Applicant Contact Songe Kang
Correspondent
Corentec Co., Ltd.
12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu,
Cheonan-si,  KR 31056
Correspondent Contact Songe Kang
Regulation Number888.3358
Classification Product Code
LPH  
Date Received10/17/2022
Decision Date 02/27/2023
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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