510(k) K252356— The Acumed Wrist Fixation System - 2.4mm Screws

Substantially Equivalent

Acumed, LLC

Clearance details

Applicant: Acumed, LLC
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2025-07-29
Decision date: 2025-08-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Hillsboro, OR, US

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.