MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU

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

DEPUY, INC.

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

Pre-market Notification Details

Device IDK860133
510k NumberK860133
Device Name:MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
ClassificationProsthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Applicant DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
ContactSteve Wentworth
CorrespondentSteve Wentworth
DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
Product CodeHRY  
CFR Regulation Number888.3530 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-14
Decision Date1986-03-10

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