MedCAD® AccuStride System— 510(k) K241811

Substantially Equivalent

Medcad

FDA 510(k) clearance K241811 for MedCAD® AccuStride System, Substantially Equivalent on 2025-03-13. Applicant: Medcad.

Clearance details

Applicant: Medcad
Product code: Code PBF
Advisory panel: Orthopedic
Date received: 2024-06-21
Decision date: 2025-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PBF

product code PBF

Injury: 180
Total: 180

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.