Engage™ Partial Knee System

Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer

Engage UNI, LLC

The following data is part of a premarket notification filed by Engage Uni, Llc with the FDA for Engage™ Partial Knee System.

Pre-market Notification Details

Device IDK190439
501k NumberK190439
Device Name:Engage™ Partial Knee System
ClassificationProsthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer
Applicant Engage UNI, LLC 5931 Brick Court, Suite 130 Winter Park,  FL  32792
ContactNicholas Slater
CorrespondentNicholas Slater
Engage Surgical 3225 N. Colorado St Chandler,  AZ  85225
Product CodeNJD  
CFR Regulation Number888.3535 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-25
Decision Date2019-11-21

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