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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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