NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE

Prosthesis, Knee, Femorotibial, Constrained, Cemented, 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 Rotatng Hinge Knee.

Pre-market Notification Details

Device IDK013385
510k NumberK013385
Device Name:NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
ClassificationProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactStephen Mckelvey
CorrespondentStephen Mckelvey
ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeKRO  
CFR Regulation Number888.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-12
Decision Date2002-01-09
Summary:summary

NIH GUDID Devices

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