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FDA 510(k)

Exactech® Equinoxe® Reverse Shoulder Glenospheres

K-Number: K193098 · 2020-02-20

ApplicantExactech, Inc.
Decision Date2020-02-20
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech® Equinoxe® Reverse Shoulder Glenospheres is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2020-02-20 under approval number K193098. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exactech® Equinoxe® Reverse Shoulder Glenospheres?

Exactech® Equinoxe® Reverse Shoulder Glenospheres is a medical device that received FDA 510(k) clearance on 2020-02-20. It is manufactured by Exactech, Inc.. The 510(k) number is K193098.

When was Exactech® Equinoxe® Reverse Shoulder Glenospheres approved by the FDA?

Exactech® Equinoxe® Reverse Shoulder Glenospheres received FDA 510(k) clearance on 2020-02-20, under approval number K193098.

What company makes Exactech® Equinoxe® Reverse Shoulder Glenospheres?

Exactech® Equinoxe® Reverse Shoulder Glenospheres is manufactured by Exactech, Inc..

What is the FDA product code for Exactech® Equinoxe® Reverse Shoulder Glenospheres?

The FDA product code for Exactech® Equinoxe® Reverse Shoulder Glenospheres is PHX.

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Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.

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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