Device typeCustom-made cranial bone prosthesis: An 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.
FDA categoryPLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
Device ID10887587064826
Catalog numberSD800405
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information