MedCAD® AccuPlate® 3DTi Patient-Specific Plating System— 510(k) K230398

Substantially Equivalent

Medcad

FDA 510(k) clearance K230398 for MedCAD® AccuPlate® 3DTi Patient-Specific Plating System, Substantially Equivalent on 2023-09-26. Applicant: Medcad.

Clearance details

Applicant: Medcad
Product code: Code JEY
Advisory panel: Dental
Date received: 2023-02-16
Decision date: 2023-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

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.