NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Nexgen Complete Knee Solution Mis Modular Tibial Plates And Keels.

Pre-market Notification Details

Device IDK052879
510k NumberK052879
Device Name:NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactBrandon Hipsher
CorrespondentBrandon Hipsher
ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-12
Decision Date2005-11-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024209268 K052879 000
00889024209251 K052879 000
00889024510418 K052879 000
00889024510401 K052879 000

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