LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation

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 Tkr System Instrumentation, Exult Tkr System Instrumentation.

Pre-market Notification Details

Device IDK222278
510k NumberK222278
Device Name:LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Corentec Co., Ltd. 12, Yeongsanhong 1-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungchongnam-do Cheonan-si,  KR 31056
ContactYoorim Bae
CorrespondentYoorim Bae
Corentec Co., Ltd. 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu, Cheonan-si, Chungchongnam-do Cheonan-si,  KR 31056
Product CodeJWH  
Subsequent Product CodeMBH
Subsequent Product CodeOQG
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-29
Decision Date2022-08-26

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