Device Dossier

Spinal fixation plate, non-biodegradable

Device Dossier for Spinal fixation plate, non-biodegradable (Spinal fixation plate, non-biodegradable, Class IIb, sponsor Prism Surgical Designs). ARTG…

Intended purpose

The device is a spinal fusion device designed to promote arthrodesis at one paired motion segment and is intended for use in the lumbar spine (L2-S1). The device is designed to restore stabililty and increase rigidity of one lumbar motion segment after total discectomy of the intervertebral disc and placement of an interbody fusion device (with graft material) to achieve a solid arthrodesis via an anterior or anterolateral surgical approach.

TGA Public Summary