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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, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K861715
Device Name WHITESIDE CONDYLAR II TOTAL KNEE PROSTHESIS
Applicant
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Applicant Contact WALTER SPIRES
Correspondent
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Correspondent Contact WALTER SPIRES
Regulation Number888.3520
Classification Product Code
HSX  
Date Received05/05/1986
Decision Date 07/14/1986
Decision Substantially Equivalent (SESE)
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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