c09bbca2-6620-4f21-8541-595586bd3cd4UpdatePublished32026-03-302022-12-082025-05-31Not in Commercial Distribution06903195108398PrimaryGS1PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T4L12H2CF26040013529652129Kontour(Xi'An) Medical Technology Co.,Ltd.1falsefalsefalsefalsefalsetruetruetruetruefalsefalsefalsefalseMR Safefalsefalse46268Cranioplasty 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