Equinoxe® Scapula Fracture System— 510(k) K243275

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K243275 for Equinoxe® Scapula Fracture System, Substantially Equivalent on 2025-06-26. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2024-10-16
Decision date: 2025-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.