NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES

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 Lps-flex Prolong Highly Crosslinked Polyethylene Articular Surfaces.

Pre-market Notification Details

Device IDK042271
510k NumberK042271
Device Name:NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES
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 Received2004-08-23
Decision Date2004-10-13
Summary:summary

NIH GUDID Devices

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