Persona Personalized Knee System

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 Persona Personalized Knee System.

Pre-market Notification Details

Device IDK193223
510k NumberK193223
Device Name:Persona Personalized Knee System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Zimmer, Inc 1800 W. Center Street Warsaw,  IN  46580
ContactGregory Foster
CorrespondentGregory Foster
Zimmer, Inc 1800 W. Center Street Warsaw,  IN  46580
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-22
Decision Date2020-01-24

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