Device Category Dossier

Cranioplasty plate, non-alterable

Device Category Dossier for Cranioplasty plate, non-alterable. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Cranioplasty plates are devices intended for reconstruction, stabilisation and rigid fixation of non load-bearing bony areas following craniotomy, craniectomy and cranial fractures. These devices are used in adults and adolescents aged 12 years and older to restore cranial bone integrity after neurosurgical procedures or traumatic injury.