FDA 510(k)

Engage™ Partial Knee System

K-Number: K190439 · 2019-11-21

Decision Date2019-11-21

Product CodeNJD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Engage™ Partial Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Engage Uni, LLC. It received FDA 510(k) clearance on 2019-11-21 under 510(k) number K190439. The device is classified under product code NJD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Engage™ Partial Knee System?

Engage™ Partial Knee System is a medical device that received FDA 510(k) clearance on 2019-11-21. The listed applicant is Engage Uni, LLC. The 510(k) number is K190439.

When did Engage™ Partial Knee System receive FDA 510(k) clearance?

Engage™ Partial Knee System received FDA 510(k) clearance on 2019-11-21, under 510(k) number K190439.

Who is the listed applicant for Engage™ Partial Knee System?

The FDA 510(k) record lists Engage Uni, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Engage™ Partial Knee System?

The FDA product code for Engage™ Partial Knee System is NJD.

Related Devices (Code: NJD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion K242307ACHIEVE Partial Knee SystemIgnite Orthomotion K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.