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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 K210614
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 Yoorim Bae
Correspondent
Corentec Co., Ltd.
12, Yeongsanhong 1-Gil, Ipjang-Myeon, Seobuk-Gu,
Cheonan-Si, Chungcheongnam-Do
Cheonan-Si,  KR 31056
Correspondent Contact Yoorim Bae
Regulation Number888.3358
Classification Product Code
LPH  
Date Received03/01/2021
Decision Date 05/24/2022
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
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