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FDA 510(k)

Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays

K-Number: K223833 · 2023-09-14

ApplicantExactech, Inc.
Decision Date2023-09-14
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2023-09-14 under approval number K223833. 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 Humeral Liners and Humeral Adapter Trays?

Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays is a medical device that received FDA 510(k) clearance on 2023-09-14. It is manufactured by Exactech, Inc.. The 510(k) number is K223833.

When was Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays approved by the FDA?

Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays received FDA 510(k) clearance on 2023-09-14, under approval number K223833.

What company makes Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays?

Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays is manufactured by Exactech, Inc..

What is the FDA product code for Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays?

The FDA product code for Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter 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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