ARIX Ankle System— 510(k) K152158

Substantially Equivalent

Jeil Medical Corporation

FDA 510(k) clearance K152158 for ARIX Ankle System, Substantially Equivalent on 2015-09-28. Applicant: Jeil Medical Corporation.

Clearance details

Applicant: Jeil Medical Corporation
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2015-08-03
Decision date: 2015-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.