510(k) K260274— Airlock® Ankle Plating System

Substantially Equivalent

Novastep SAS

Clearance details

Applicant: Novastep SAS
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2026-01-29
Decision date: 2026-03-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Rennes, FR

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.