Device typeCranioplasty plate, non-alterable: An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.
FDA categoryPlate, Cranioplasty, Preformed, Non-Alterable
Device ID00810007631035
Catalog numberMC-AST10
AvailabilityPrescription
Single useYes
MRI safetyMR Unsafe