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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 K902538
Device Name WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION
Applicant
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Applicant Contact DEERE PATTON
Correspondent
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Correspondent Contact DEERE PATTON
Regulation Number888.3530
Classification Product Code
HRY  
Date Received06/06/1990
Decision Date 07/06/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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