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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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