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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 K232175
Device Name XN Knee Prosthesis System
Applicant
Beijing Chunlizhengda Medical Instruments Co., Ltd.
# 10 Xinmi W. 2nd Rd., Southern District Of Tongzhou
Economic Development Zone, Tongzho
Beijing,  CN 101112
Applicant Contact Xie Fengbao
Correspondent
MCRA, LLC
803 7th St. NW
Floor 3
Washington,  DC  20001
Correspondent Contact Dave McGurl
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/21/2023
Decision Date 04/14/2024
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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