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 ulrich screw-rod systems are used for surgical stabilization of the thoracic and lumbar spine and sacrum; misalignment of the cervical spine in humans including the occipitocervical and cervicothoracic transitions if necessary. The indications for use include: degenerative spondylolisthesis with distinctive evidence of neurological impairment, vertebral fracture, spinal tumor, dislocation, scoliosis, deformity, failed previous fusion, occipitocervical, cervical or cervicothoracic, mono- or multisegmental instabilities of rheumatic, traumatic, neoplastic, congenital and iatrogenic genesis, degenerative diseases, pseudarthrosis, spinal stenosis, destruction and instability.

TGA Public Summary