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INDICATIONS, SAFETY, AND WARNINGS Mazor X Robotic Guidance System

INDICATIONS FOR USE

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

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