Device Dossier

Robot, surgical, navigation unit

Device Dossier for Robot, surgical, navigation unit (Robot, surgical, navigation unit, Class IIa, sponsor Medtronic). ARTG record, intended purpose, GMDN…

Intended purpose

The Renaissance System is indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It may be used in open or minimally invasive or percutaneous procedures. Renaissance 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.

TGA Public Summary