Device Dossier

Optical surgical navigation device tracking system

Device Dossier for Optical surgical navigation device tracking system (Optical surgical navigation device tracking system, Class IIa, sponsor Life…

Intended purpose

The system is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified from CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae

TGA Public Summary