0c05ac9d-1032-44ae-a123-cdb43b2b1103UpdatePublished22025-06-092024-10-10In Commercial DistributionM384CF260200070PrimaryHIBCCCranioFitKT-T2L7H1CF26020007838734093Bioplate, Inc.1CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) falsefalsefalsefalsefalsetruetruefalsetruefalsefalsefalsefalseMR Safetruefalse8882467528INFO@bioplate.com46268Cranioplasty plate, non-alterableAn 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.trueActiveGXNPlate, Cranioplasty, Preformed, Non-AlterablefalsetrueMoist Heat or Steam Sterilization