Spine Navigation and Robotic-Assistance Device

The Subject Device and its predicates are indicated:
- for open or percutaneous spinal procedures.
- for a use based on the identification of the bony structure of the spine.
- to be used by surgeons.
- for the placement of spinal implants.

The Subject Device and its predicates are indicated: - for open or percutaneous spinal procedures. - for a use based on the identification of the bony structure of the spine. - to be used by surgeons. - for the placement of spinal implants.

The Subject Device and its predicates are intended: - to position and orientate surgical instruments - to be used in Freehand Navigation Guidance Mode and Robotic-Assisted Guidance mode. The Subject Device and its predicates are substantially equivalent in terms of: - General technology description. - Principles of operation of the Robotic-Assisted Guidance Mode. - Principles of operation of the Freehand Navigation Mode. - Operation Principles (SURGIVISIO Device allows to navigate targeting needles.) - Surgical workflow in Freehand Navigation. - Surgical workflow in Robotic-Assisted Guidance. - DICOM compatibility. - User's Control. - Graphical User Interface.