The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws— 510(k) K251132

Substantially Equivalent

Acumed, LLC

FDA 510(k) clearance K251132 for The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws, Substantially Equivalent on 2025-07-14. Applicant: Acumed, LLC.

Clearance details

Applicant: Acumed, LLC
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2025-04-11
Decision date: 2025-07-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hillsboro, OR, 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.