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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 K161705
Device Name U2 Total Knee System E-XPE products
Applicant
UNITED ORTHOPEDIC CORPORATION
NO 57, PARK AVE 2
SCIENCE PARK
HSINCHU,  TW 300
Applicant Contact KAREN HO
Correspondent
UNITED ORTHOPEDIC CORPORATION
NO 57, PARK AVE 2
SCIENCE PARK
HSINCHU,  TW 300
Correspondent Contact KAREN HO
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OIY  
Date Received06/20/2016
Decision Date 03/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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