Device Dossier

Bone-screw internal spinal fixation system, non-sterile

Device Dossier for Bone-screw internal spinal fixation system, non-sterile (Bone-screw internal spinal fixation system, non-sterile, Class IIb, sponsor…

Intended purpose

The device is indicated for spinal fixation including: 1) Degenerative diseases (eg, disc herniation, spinal stenosis, spondylolisthesis, lumbar instability); 2) Spinal deformities (eg, scoliosis, humpback and / or lordosis); 3) trauma (eg, fracture, and / or dislocation); 4) pseudarthrosis, tumor resection, and / or previous fusion fails.

TGA Public Summary