SYNATOMIC VARIABLE FIT TIBIAL PLATEAU

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/composite

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Synatomic Variable Fit Tibial Plateau.

Pre-market Notification Details

Device IDK851341
510k NumberK851341
Device Name:SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
ClassificationProsthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/composite
Applicant DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
ContactJudith Dermody
CorrespondentJudith Dermody
DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
Product CodeKYK  
CFR Regulation Number888.3500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-03
Decision Date1985-07-15

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