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 IDK210551
510k NumberK210551
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
ContactRomil Sheth
CorrespondentRomil Sheth
Zimmer, Inc. 1800 W. Center Street Warsaw,  IN  46580
Product CodeJWH  
Subsequent Product CodeMBH
Subsequent Product CodeOIY
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-25
Decision Date2021-03-18

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