Device Dossier

Skull Base Plates - Suboccipital - Cranioplasty plate, non-alterable

Device Dossier for Skull Base Plates - Suboccipital - Cranioplasty plate, non-alterable (Cranioplasty plate, non-alterable, Class III, sponsor Stryker).…

Intended purpose

Intended for reconstruction, stabilization and/or rigid fixation of non load-bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).

Functional description

The Universal Neuro III Suboccipital Skull Base Plate is characterized by its “butterfly-shaped” design to allow reconstruction, stabilization and/or rigid fixation of non load-bearing bony areas following the midline suboccipital approach. A closed outer frame design with multiple fixation holes within the centre of the plate and additional fixation holes in the closed outer frame. The suboccipital plate is available in two sizes (small and large).

TGA Public Summary