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FDA 510(k)

Equinoxe® Scapula Fracture System

K-Number: K243275 · 2025-06-26

ApplicantExactech, Inc.
Decision Date2025-06-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Equinoxe® Scapula Fracture System is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2025-06-26 under 510(k) number K243275. 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 Equinoxe® Scapula Fracture System?

Equinoxe® Scapula Fracture System is a medical device that received FDA 510(k) clearance on 2025-06-26. The listed applicant is Exactech, Inc.. The 510(k) number is K243275.

When did Equinoxe® Scapula Fracture System receive FDA 510(k) clearance?

Equinoxe® Scapula Fracture System received FDA 510(k) clearance on 2025-06-26, under 510(k) number K243275.

Who is the listed applicant for Equinoxe® Scapula Fracture System?

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 Equinoxe® Scapula Fracture System?

The FDA product code for Equinoxe® Scapula Fracture System is HRS.

Other records listing Exactech, Inc. as applicant

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Related Devices (Code: HRS)

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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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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