Device Dossier

Spinal cage

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

Intended purpose

The Additive Surgical PorOssity devices are intended to restore intervertebral height and to facilitate intervertebral body fusion in the lumbar spine column (L2-S1). The Additive Surgical PorOssity Lumbar Devices are indicated for use in skeletally mature patients with; degenerative disc diseases, spinal stenosis, spondylolisthesis, trauma, tumours, pseudarthrosis, and instability of motion segments. As a complementary device, it should NOT be used as a stand-alone but must be used in combination with other spinal fixation systems (e.g. pedicle screws). The devices are designed to be applied with Lumbar surgical techniques and must always be within the limits of the vertebral cortices and on skeletally mature patients.

TGA Public Summary