Persona Revision 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 Revision Knee System.

Pre-market Notification Details

Device IDK191625
510k NumberK191625
Device Name:Persona Revision Knee System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Zimmer Inc. 1800 W. Center Street Warsaw,  IN  46580
ContactNicole Meredith
CorrespondentNicole Meredith
Zimmer Inc. 1800 W. Center Street Warsaw,  IN  46580
Product CodeJWH  
Subsequent Product CodeMBH
Subsequent Product CodeOIY
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-18
Decision Date2019-09-05
Summary:summary

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