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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 K122183
Device Name AUGMENT AND SCREW, PSA TYPE
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 Received07/23/2012
Decision Date 02/05/2013
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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