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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 K140073
Device Name U2 FEMORAL COMPONENT, CR, CEMENTED
Applicant
United Orthopedic Corp.
# 57, Park Ave. 2, Science Park
Hsinchu,  TW 300
Applicant Contact FANG-YUAN HO
Correspondent
United Orthopedic Corp.
# 57, Park Ave. 2, Science Park
Hsinchu,  TW 300
Correspondent Contact FANG-YUAN HO
Regulation Number888.3560
Classification Product Code
JWH  
Date Received01/13/2014
Decision Date 06/16/2014
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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