8525dfb8-ca57-4f86-9c89-1eef8c54be73NewPublished22018-07-062018-06-012018-06-01Not in Commercial Distribution00817580021925PrimaryGS1Kelyniam CSI PEEK-IM1002PEEK-IM1002785088829KELYNIAM GLOBAL, INC.1PEEK Customized Cranial Implant, MediumfalsefalsefalsefalsefalsetruetruetruetruetruetruefalsetrueMR SafetruefalseK10358200046268Cranioplasty 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