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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 K120507
Device Name UNITED U2 FEMORAL COMPONENT, PS, #7
Applicant
UNITED ORTHOPEDIC CORPORATION
NO 57, PARK AVE 2,
SCIENCE PARK
HSINCHU,  TW 300
Applicant Contact FANG-YUAN HO
Correspondent
UNITED ORTHOPEDIC CORPORATION
NO 57, PARK AVE 2,
SCIENCE PARK
HSINCHU,  TW 300
Correspondent Contact FANG-YUAN HO
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/21/2012
Decision Date 05/04/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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