Device Dossier
Skull Base Plates -Translabyrinthine - Cranioplasty plate, non-alterable
Device Dossier for Skull Base Plates -Translabyrinthine - Cranioplasty plate, non-alterable (Cranioplasty plate, non-alterable, Class III, sponsor…
- GMDN category: Cranioplasty plate, non-alterable
- 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 translabyrinthine plates for reconstruction, stabilization and/or rigid fixation of non load-bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures have a low profile of 0.3mm with a “triangular shaped” design for the mastoid area. A closed outer frame design with multiple fixation holes within the centre of the plate and additional fixation bars at the closed outer frame.