Device Dossier

Stereotactic surgery system, multi-purpose

Device Dossier for Stereotactic surgery system, multi-purpose (Stereotactic surgery system, multi-purpose, Class IIa, sponsor Medtronic). ARTG record,…

Intended purpose

An assembly of devices that may consist of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline (e.g., orthopaedic and ENT). The system may include computerized functions to store diagnostic images used for image-guided surgery.

TGA Public Summary