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FDA 510(k)

Exactech® Equinoxe® Stemless Humeral Components

K-Number: K192097 · 2020-04-29

ApplicantExactech, Inc.
Decision Date2020-04-29
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech® Equinoxe® Stemless Humeral Components is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2020-04-29 under approval number K192097. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exactech® Equinoxe® Stemless Humeral Components?

Exactech® Equinoxe® Stemless Humeral Components is a medical device that received FDA 510(k) clearance on 2020-04-29. It is manufactured by Exactech, Inc.. The 510(k) number is K192097.

When was Exactech® Equinoxe® Stemless Humeral Components approved by the FDA?

Exactech® Equinoxe® Stemless Humeral Components received FDA 510(k) clearance on 2020-04-29, under approval number K192097.

What company makes Exactech® Equinoxe® Stemless Humeral Components?

Exactech® Equinoxe® Stemless Humeral Components is manufactured by Exactech, Inc..

What is the FDA product code for Exactech® Equinoxe® Stemless Humeral Components?

The FDA product code for Exactech® Equinoxe® Stemless Humeral Components is PKC.

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Related Devices (Code: PKC)

K171858Sidus Stem-Free ShoulderZimmer GmbH K173388Exactech Equinoxe Stemless ShoulderExactech, Inc. K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc. K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.

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.

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