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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 K082424
Device Name UNITED U2 TOTAL KNEE SYSTEM
Applicant
UNITED ORTHOPEDIC CORP.
57 PARK AVE. 2, SCIENCE PARK
HSINCHU,  TW 300
Applicant Contact RUDY CHEN
Correspondent
UNITED ORTHOPEDIC CORP.
57 PARK AVE. 2, SCIENCE PARK
HSINCHU,  TW 300
Correspondent Contact RUDY CHEN
Regulation Number888.3560
Classification Product Code
JWH  
Date Received08/22/2008
Decision Date 12/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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