ARIX Clavicle System— 510(k) K180972

Substantially Equivalent

Jeil Medical Corporation

FDA 510(k) clearance K180972 for ARIX Clavicle System, Substantially Equivalent on 2018-10-03. Applicant: Jeil Medical Corporation.

Clearance details

Applicant: Jeil Medical Corporation
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2018-04-13
Decision date: 2018-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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.