K242751

Substantially Equivalent

ARIX Pectus Bar System

Applicant: Jeil Medical Corporation
Product code: HRS
Advisory panel: Orthopedic
Date received: 2024-09-12
Decision date: 2025-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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.