34cfac6e-a586-4dc9-afd8-3245e1fa4cbfNewPublished12021-12-102021-12-02In Commercial Distribution00810077241981PrimaryGS1HTR-PEKKPK624346-A962301359OXFORD PERFORMANCE MATERIALS, INC.1falsefalsefalsefalsefalsetruetruefalsetruefalsefalsefalsefalseMR Safetruefalse904-741-4400fxjax-orders@biomet.comK16105200058908Custom-made cranial bone prosthesisAn implantable device intended to repair a defect of the cranium or mandible that is designed and constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specified patient. It is typically manufactured from a three-dimensional (3-D) model based on computed tomography (CT) images and made of plastic [e.g., ultrahigh molecular weight polyethylene (UHMWPE), polyetheretherketone (PEEK)] and/or metal [e.g., titanium (Ti)]. The device may be used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease, or for cosmetic/aesthetic purposes.trueActiveKKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial ReconstructionfalsetrueMoist Heat or Steam Sterilization