NEXGEN COMPLETE KNEE SOLUTION

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.

Pre-market Notification Details

Device IDK963148
510k NumberK963148
Device Name:NEXGEN COMPLETE KNEE SOLUTION
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactRuth Ann Wood
CorrespondentRuth Ann Wood
ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-13
Decision Date1997-02-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024228108 K963148 000
00889024228092 K963148 000
00889024228085 K963148 000
00889024228078 K963148 000
00889024228061 K963148 000
00889024228054 K963148 000
00889024228047 K963148 000
00889024228030 K963148 000

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