EXULT Femoral Component Trial - Left, EXULT Femoral Component Trial - Right

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 Exult Femoral Component Trial - Left, Exult Femoral Component Trial - Right.

Pre-market Notification Details

Device IDK201851
510k NumberK201851
Device Name:EXULT Femoral Component Trial - Left, EXULT Femoral Component Trial - Right
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
CorrespondentSungwon Yang
Corentec Co., Ltd 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu Cheonan-si,  KR 31056
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-06
Decision Date2020-07-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800068942524 K201851 000
08800068942388 K201851 000
08800068942371 K201851 000
08800068942364 K201851 000
08800068942357 K201851 000
08800068942340 K201851 000
08800068942333 K201851 000
08800068942326 K201851 000
08800068942319 K201851 000
08800068942302 K201851 000
08800068942289 K201851 000
08800068942395 K201851 000
08800068942401 K201851 000
08800068942418 K201851 000
08800068942517 K201851 000
08800068942500 K201851 000
08800068942494 K201851 000
08800068942487 K201851 000
08800068942470 K201851 000
08800068942463 K201851 000
08800068942456 K201851 000
08800068942449 K201851 000
08800068942432 K201851 000
08800068942425 K201851 000
08800068942272 K201851 000

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