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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 K211866
Device Name Bencox THR System
Applicant
Corentec Co., Ltd.
12, Yeongsanhong 1-Gil, Ipjang-Myeon, Seobuk Gu
Cheonan,  KR 31056
Applicant Contact Seungri Kim
Correspondent
Corentec Co., Ltd.
12, Yeongsanhong 1-Gil, Ipjang-Myeon, Seobuk Gu
Cheonan,  KR 31056
Correspondent Contact Sungwon Yang
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWY   LZO  
Date Received06/16/2021
Decision Date 07/14/2021
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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