FDA 510(k)

Exactech Equinoxe Humeral Augmented Trays

K-Number: K191561 · 2019-08-20

Decision Date2019-08-20

Product CodePHX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Exactech Equinoxe Humeral Augmented Trays is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2019-08-20 under 510(k) 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. The listed applicant is Exactech, Inc.. The 510(k) number is K191561.

When did Exactech Equinoxe Humeral Augmented Trays receive FDA 510(k) clearance?

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

Who is the listed applicant for Exactech Equinoxe Humeral Augmented Trays?

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

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

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

Other records listing Exactech, Inc. as applicant

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.

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Related Devices (Code: PHX)

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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.