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510(k) K190439

Device
Engage™ Partial Knee System
Applicant
Engage UNI, LLC
510(k) number
K190439
Product code
NJD  
Decision
Substantially Equivalent (SESE)
Decision date
2019-11-21
Date received
2019-02-25
Regulation
888.3535
Classification name
Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Nicholas Slater
Address
5931 Brick Ct. Suite 130 Winter Park FL US 32792 32792

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NJD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion2025-09-02
K242307ACHIEVE Partial Knee SystemIgnite Orthomotion2024-12-16
K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.2022-10-28
K133811RESTORIS POROUS PARTIAL KNEE SYSTEMMako Surgical Corp.2014-07-08

Legacy Summary#

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FDA Review#

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