SOLE Medial Column Fusion Plate— 510(k) K210157

Substantially Equivalent

Orthofix Srl

FDA 510(k) clearance K210157 for SOLE Medial Column Fusion Plate, Substantially Equivalent on 2021-04-20. Applicant: Orthofix Srl.

Clearance details

Applicant: Orthofix Srl
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2021-01-21
Decision date: 2021-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bussolengo, IT

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.