Effects of a Spine Navigation System on Op-time and Radiation Exposure

"The intended use of the MvIGS navigation system is to provide high quality intraoperative imaging with no radiation exposure. Use of the proprietary integrated surgical light with embedded tracking technology and Flash™ registration allows for continuous and direct visualization of the surgical field. The MvIGS system is exempt from IDE regulations as the device cleared Premarket Notification FDA-510(k) (K162375). The device includes:~* A single mobile cart with a boom arm and an integrated surgical light with embedded tracking technology (P/N 10-0001);~* Proprietary imaging software (P/N 60-0007); and,~* Kit of tacked surgical instruments including a spine reference clamp, awl tip, pedicle probe (P/N 11-0006)."