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FDA 510(k)

Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws

K-Number: K223933 · 2023-09-25

ApplicantExactech, Inc.
Decision Date2023-09-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2023-09-25 under 510(k) number K223933. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws?

Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws is a medical device that received FDA 510(k) clearance on 2023-09-25. The listed applicant is Exactech, Inc.. The 510(k) number is K223933.

When did Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws receive FDA 510(k) clearance?

Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws received FDA 510(k) clearance on 2023-09-25, under 510(k) number K223933.

Who is the listed applicant for Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws?

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 PHx Fracture System; Exactech EPIC Screws?

The FDA product code for Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws is HRS.

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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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