Device Dossier

Skull Base Plates - Mesh, Round - Cranioplasty plate, non-alterable

Device Dossier for Skull Base Plates - Mesh, Round - 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 Mesh Skull Base Plate is characterized by its circular-shaped that allows reconstruction, stabilization and/or rigid fixation of non load-bearing bony areas for circular bony defects eg. when performing the retrosigmoid 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 plate is available in three sizes (small, medium and large).

TGA Public Summary