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 Evolution Surgical spinal fixation system is a system composed of screws, rods, cross-connectors, staples, hooks and rod connectors for spinal surgery. The implants are available in various sizes for optimal adaptation of the pathology of the individual patient. The system is indicated for single use with paediatric and skeletally matured patients for rigid fixation and stability who present with acute or chronic instabilities or deformities.

TGA Public Summary