ARIX Cannulated Screw System— 510(k) K233912

Substantially Equivalent

Jeil Medical Corporation

FDA 510(k) clearance K233912 for ARIX Cannulated Screw System, Substantially Equivalent on 2024-03-11. Applicant: Jeil Medical Corporation.

Clearance details

Applicant: Jeil Medical Corporation
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2023-12-12
Decision date: 2024-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.