Device Category Dossier

Prosthesis, internal, ear/nose/throat, synthetic

Device Category Dossier for Prosthesis, internal, ear/nose/throat, synthetic. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Device: MEDPOR Customized Cranial Implant - Prosthesis, internal, ear/nose/throat, synthetic
Device: Prosthesis, internal, ear/nose/throat, synthetic
Device: Prosthesis, internal, ear/nose/throat, synthetic
Device: Prosthesis, internal, ear/nose/throat, synthetic
Device: Prosthesis, internal, ear/nose/throat, synthetic
Device: Prosthesis, internal, ear/nose/throat, synthetic
Device: Prosthesis, internal, ear/nose/throat, synthetic
Device: Prosthesis, internal, ear/nose/throat, synthetic

Craniofacial implants are anatomically shaped surgical implants manufactured from porous high-density polyethylene with a star-shaped particle architecture that creates an interconnecting porous structure resembling trabecular bone. These devices are intended for permanent implantation to restore or augment bony contour in craniofacial defects in non-weight bearing applications, including reconstruction following trauma, surgery, or congenital abnormalities.