Device typePolyethylene craniofacial tissue reconstructive material: A sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device.
FDA categoryMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device ID00815285024883
Catalog number4753
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Safe