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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.
NO. 57, PARK AVE 2, SCIENCE PARK
HSINCHU,  TW 300
Applicant Contact FANG-YUAN HO
Correspondent
UNITED ORTHOPEDIC CORP.
NO. 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
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