INDICATIONS, SAFETY, AND WARNINGS Mazor X Robotic Guidance System

INDICATIONS FOR USE

The Mazor X™ System is indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It may be used in either open or minimally-invasive or percutaneous procedures.

Mazor X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into a volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.

The Mazor X Navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.

Contraindications

Do not use the Mazor X system with any patient who has been diagnosed or is suspected of having Creutzfeldt-Jakob disease (CJD).