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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 K161360
Device Name U2 Total Knee System, PSA Tibial Insert
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  
Date Received05/16/2016
Decision Date 02/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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