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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 a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2025-06-26 under approval 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. It is manufactured by Exactech, Inc.. The 510(k) number is K243275.

When was Equinoxe® Scapula Fracture System approved by the FDA?

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

What company makes Equinoxe® Scapula Fracture System?

Equinoxe® Scapula Fracture System is manufactured by Exactech, Inc..

What is the FDA product code for Equinoxe® Scapula Fracture System?

The FDA product code for Equinoxe® Scapula Fracture System 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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