Salvo® Robotic Navigation Instruments

The Salvo® Robotic Navigation Instruments are surgical instruments designed for use with Globus Medical's ExcelsiusGPS® Robotic Navigation Platform to facilitate placement of Salvo® Spine System screws during open or minimally invasive spinal surgery. The instruments help surgeons locate anatomical structures and position instrument holders or guide tubes for navigating compatible surgical instruments.

The Salvo® Robotic Navigation Instruments have equivalent technological characteristics to predicate devices, including similar device design and dimensions, materials of manufacture, and principles of operation. Like the predicates, they are non-sterile, reusable instruments to be steam sterilized by the end user.

Not stated in this summary.

The subject device has the same intended use as the primary predicate (E-GPS Navigated Instruments) — both are used during preparation and placement of screws in open or minimally invasive spinal procedures with a robotic navigation platform. Dimensional analysis, geometric comparison, and validation testing for compatibility with the ExcelsiusGPS end effector demonstrated equivalent safety and effectiveness for accuracy performance. Since the technological characteristics and principles of operation are substantially similar and no new safety or effectiveness issues are raised, substantial equivalence is established.