EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM— 510(k) K131298

Name: FDA 510(k) clearance K131298
Creator: U.S. Food and Drug Administration
Published: 2013-11-26

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K131298 for EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM, Substantially Equivalent on 2013-11-26. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant: Exactech, Inc.
Product code: Code HSD
Device class: Class 2
Regulation: 21 CFR 888.3690
Advisory panel: Orthopedic
Date received: 2013-05-06
Decision date: 2013-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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K243275 — Equinoxe® Scapula Fracture System2025-06-26
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Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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.