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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, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K020741
Device Name UNICONDYLAR KNEE
Applicant
Encore Orthopedics, Inc.
9800 Metric Blvd.
Austin,  TX  78758
Applicant Contact JOANNA DROEGE
Correspondent
Encore Orthopedics, Inc.
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact JOANNA DROEGE
Regulation Number888.3530
Classification Product Code
HRY  
Date Received03/06/2002
Decision Date 06/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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