MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM

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

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Miller/galante Precoat Unicompartmental Knee System.

Pre-market Notification Details

Device IDK942263
510k NumberK942263
Device Name:MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactRuth A Wood
CorrespondentRuth A Wood
ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-09
Decision Date1995-07-11

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