FIX-C PEEK ACIF SA System— 510(k) K251431

Substantially Equivalent

Jeil Medical Corporation

FDA 510(k) clearance K251431 for FIX-C PEEK ACIF SA System, Substantially Equivalent on 2025-06-27. Applicant: Jeil Medical Corporation.

Clearance details

Applicant: Jeil Medical Corporation
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2025-05-08
Decision date: 2025-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.