Device Dossier

Fixation system, internal, spinal, bone screw

Device Dossier for Fixation system, internal, spinal, bone screw (Fixation system, internal, spinal, bone screw, Class IIb, sponsor Emergo). ARTG record,…

Intended purpose

The pedicle screw and fixation rod system is indicated for stabilisation of the spine until stability has been achieved in patients who have undergone surgical fusion of the spine. Indications for all pedicle screw systems: Instability of the spine or deviations from the normal position of the spine, Fractures, Postoperative or degenerative instability, Tumours and spondylodiscitis, Correction of Meyerding grade 1 spondylolisthesis, Disc prolapse, Stenoses of the lumbar spine, Disc resection, Abnormal lordosis/kyphosis/scoliosis and Degenerative segmental disease. The system is furthermore indicated in situations where external immobilisation by means of a plaster cast or splint is not possible.

TGA Public Summary