Engage Partial Knee System
K-Number: K190439 · 2019-11-21
ApplicantEngage Uni, LLC
Decision Date2019-11-21
Product CodeNJD
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Engage Partial Knee System is a medical device manufactured by Engage Uni, LLC. It received FDA 510(k) clearance on 2019-11-21 under approval 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. It is manufactured by Engage Uni, LLC. The 510(k) number is K190439.
When was Engage Partial Knee System approved by the FDA?
Engage Partial Knee System received FDA 510(k) clearance on 2019-11-21, under approval number K190439.
What company makes Engage Partial Knee System?
Engage Partial Knee System is manufactured by Engage Uni, LLC.
What is the FDA product code for Engage Partial Knee System?
The FDA product code for Engage Partial Knee System is NJD.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.