Bencox THR System

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Corentec Co., Ltd.

The following data is part of a premarket notification filed by Corentec Co., Ltd. with the FDA for Bencox Thr System.

Pre-market Notification Details

Device IDK211866
510k NumberK211866
Device Name:Bencox THR System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Corentec Co., Ltd. 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu Cheonan-si,  KR 31056
ContactSeungri Kim
CorrespondentSungwon Yang
Corentec Co., Ltd. 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu Cheonan-si,  KR 31056
Product CodeJWH  
Subsequent Product CodeKWY
Subsequent Product CodeLPH
Subsequent Product CodeLZO
Subsequent Product CodeMBH
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-16
Decision Date2021-07-14

NIH GUDID Devices

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