LOSPA II Knee System (EXULT Knee Replacement 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 Lospa Ii Knee System (exult Knee Replacement System).

Pre-market Notification Details

Device IDK200395
510k NumberK200395
Device Name:LOSPA II Knee System (EXULT Knee Replacement 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
ContactSungwon Yang
CorrespondentYoorim Bae
Corentec Co., Ltd. Banpo-daero 20-gil, 33-2, Seocho Gu, Seoul,  KR 06649
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-18
Decision Date2020-05-07

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