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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 K881779
Device Name WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM
Applicant
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Applicant Contact LIPSCOMB, PHD
Correspondent
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Correspondent Contact LIPSCOMB, PHD
Regulation Number888.3520
Classification Product Code
HSX  
Date Received04/26/1988
Decision Date 08/31/1988
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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