IBalance UKA Tibial Tray Implant

Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

Arthrex Inc.

The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Ibalance Uka Tibial Tray Implant.

Pre-market Notification Details

Device IDK200433
510k NumberK200433
Device Name:IBalance UKA Tibial Tray Implant
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108
ContactIvette Galmez
CorrespondentIvette Galmez
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-21
Decision Date2020-03-17

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