Device Dossier

Spinal fixation plate, non-biodegradable

Device Dossier for Spinal fixation plate, non-biodegradable (Spinal fixation plate, non-biodegradable, Class IIb, sponsor Emergo). ARTG record, intended…

Intended purpose

The plate and screw systems serve to temporarily stabilise the spine until solid bony fusion is complete. They are not suitable for replacing body structures nor for permanently absorbing forces arising in cases where fusion has not taken place. Application is via anterior access in patients with instabilities that may be due to the following reasons: Degenerative disc disease, Spinal canal stenosis, Spondylolisthesis, Trauma, Tumour and inflammation without bone involvement at the site of fixation, Deformity, Pseudoarthrosis, and Absence of fusion.

TGA Public Summary