Device Dossier

Spinal cage

Device Dossier for Spinal cage (Spinal cage, Class IIb, sponsor 3DMorphic). ARTG record, intended purpose, GMDN category — compiled by arcimedes.

Intended purpose

The device is indicated for use in the cervical, thoraco-lumbar, lumbar or lumbo-sacral spine, and is intended to immobilize, stabilise and maintain the space between instrumented spinal segments. The device provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. The device is intended for use with integral screw fixation, and may require the use of supplemental fixation to stabilise the fusion site.

TGA Public Summary