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FDA 510(k)

Exactech Equinoxe Humeral Augmented Trays

K-Number: K191561 · 2019-08-20

ApplicantExactech, Inc.
Decision Date2019-08-20
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech Equinoxe Humeral Augmented Trays is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2019-08-20 under approval number K191561. 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 Humeral Augmented Trays?

Exactech Equinoxe Humeral Augmented Trays is a medical device that received FDA 510(k) clearance on 2019-08-20. It is manufactured by Exactech, Inc.. The 510(k) number is K191561.

When was Exactech Equinoxe Humeral Augmented Trays approved by the FDA?

Exactech Equinoxe Humeral Augmented Trays received FDA 510(k) clearance on 2019-08-20, under approval number K191561.

What company makes Exactech Equinoxe Humeral Augmented Trays?

Exactech Equinoxe Humeral Augmented Trays is manufactured by Exactech, Inc..

What is the FDA product code for Exactech Equinoxe Humeral Augmented Trays?

The FDA product code for Exactech Equinoxe Humeral Augmented Trays is PHX.

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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.

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