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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K230120
Device Name KeYi Total Knee System
Applicant
Beijing KeYi Medical Device Technology Co., Ltd.
Building 1, 30 Yongchang South Road
Beijing,  CN 100176
Applicant Contact Jenny Jiang
Correspondent
Beijing KeYi Medical Device Technology Co., Ltd.
Building 1, 30 Yongchang South Road
Beijing,  CN 100176
Correspondent Contact Jenny Jiang
Regulation Number888.3560
Classification Product Code
JWH  
Date Received01/17/2023
Decision Date 04/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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