Device Dossier

Bone-screw internal spinal fixation system, sterile

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

Intended purpose

The Z-Medical screw and rod products are used for the surgical stabilisation of the spine. The Z-pedicle screws are indicated for fixation, reconstruction and stabilization of vertebrae for treatment of Degenerative disc disease (DDD) (defined as backpain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, spinal stenosis, curvatures (scoliosis, kyphosis and / or lordosis), tumour, pseudoarthrosis and failed previous fusion.

TGA Public Summary