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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 K012800
Device Name SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
Applicant
Whiteside Biomechanics, Inc.
12634 Olive Blvd.
Creve Coeur,  MO  63141
Applicant Contact DEBRA MEYER
Correspondent
Whiteside Biomechanics, Inc.
12634 Olive Blvd.
Creve Coeur,  MO  63141
Correspondent Contact DEBRA MEYER
Regulation Number888.3530
Classification Product Code
HRY  
Date Received08/21/2001
Decision Date 05/03/2002
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
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