Journey II XR Knee Instrument

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Smith & Nephew, Inc

The following data is part of a premarket notification filed by Smith & Nephew, Inc with the FDA for Journey Ii Xr Knee Instrument.

Pre-market Notification Details

Device IDK200227
510k NumberK200227
Device Name:Journey II XR Knee Instrument
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Smith & Nephew, Inc 7135 Goodlett Farms Parkway Cordova,  TN  38016
ContactMeenakshi Gupta
CorrespondentBrad Sheals
Smith & Nephew, Inc 7135 Goodlett Farms Parkway Cordova,  TN  38016
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-30
Decision Date2020-06-04

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.