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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 K021657
Device Name UKNEE TOTAL KNEE SYSTEM
Applicant
UNITED ORTHOPEDIC CORP.
57 PARK AVE. 2, SCIENCE PARK
HSINCHU,  TW 300
Applicant Contact PHILIP LEUNG
Correspondent
UNITED ORTHOPEDIC CORP.
57 PARK AVE. 2, SCIENCE PARK
HSINCHU,  TW 300
Correspondent Contact PHILIP LEUNG
Regulation Number888.3560
Classification Product Code
JWH  
Date Received05/20/2002
Decision Date 08/12/2002
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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