FDA 510(k)

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System

N.º K: K230398 · 2023-09-26

SolicitanteMedcad

Fecha de decisión2023-09-26

Código de productoJEY

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Medcad. It received FDA 510(k) clearance on 2023-09-26 under 510(k) number K230398. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MedCAD® AccuPlate® 3DTi Patient-Specific Plating System?

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is a medical device that received FDA 510(k) clearance on 2023-09-26. The listed applicant is Medcad. The 510(k) number is K230398.

When did MedCAD® AccuPlate® 3DTi Patient-Specific Plating System receive FDA 510(k) clearance?

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System received FDA 510(k) clearance on 2023-09-26, under 510(k) number K230398.

Who is the listed applicant for MedCAD® AccuPlate® 3DTi Patient-Specific Plating System?

The FDA 510(k) record lists Medcad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MedCAD® AccuPlate® 3DTi Patient-Specific Plating System?

The FDA product code for MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is JEY.

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Fuente oficial

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