NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO

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 Legacy Posterior Stabilized (lps); Lps-flex Fixed Bearing Femoral And Articular Surface Co.

Pre-market Notification Details

Device IDK991581
510k NumberK991581
Device Name:NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/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 CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-07
Decision Date1999-07-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024209275 K991581 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.