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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/Composite
510(k) Number K851341
Device Name SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
Applicant
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Applicant Contact JUDITH DERMODY
Correspondent
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Correspondent Contact JUDITH DERMODY
Regulation Number888.3500
Classification Product Code
KYK  
Date Received04/03/1985
Decision Date 07/15/1985
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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