FDA 510(k)

MedCAD AccuShape Titanium Patient-Specific Cranial Implant

N.º K: K220357 · 2022-08-26

SolicitanteMedcad

Fecha de decisión2022-08-26

Código de productoGXN

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

MedCAD AccuShape Titanium Patient-Specific Cranial Implant is the device name listed in this FDA 510(k) record. The listed applicant is Medcad. It received FDA 510(k) clearance on 2022-08-26 under 510(k) number K220357. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MedCAD AccuShape Titanium Patient-Specific Cranial Implant?

MedCAD AccuShape Titanium Patient-Specific Cranial Implant is a medical device that received FDA 510(k) clearance on 2022-08-26. The listed applicant is Medcad. The 510(k) number is K220357.

When did MedCAD AccuShape Titanium Patient-Specific Cranial Implant receive FDA 510(k) clearance?

MedCAD AccuShape Titanium Patient-Specific Cranial Implant received FDA 510(k) clearance on 2022-08-26, under 510(k) number K220357.

Who is the listed applicant for MedCAD AccuShape Titanium Patient-Specific Cranial Implant?

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 AccuShape Titanium Patient-Specific Cranial Implant?

The FDA product code for MedCAD AccuShape Titanium Patient-Specific Cranial Implant is GXN.

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Otros registros que enlistan a Medcad como solicitante

K252064MedCAD® AccuStride™ System K251709MedCAD® AccuStride™ System K241811MedCAD® AccuStride™ System K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating System K223421MedCAD AccuPlan Orthopedics System K223024MedCAD AccuPlan System

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Dispositivos relacionados (Código: GXN)

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Fuente oficial

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