Practical Navigation Surgical Guidance System (PNSGS)

Practical Navigation Surgical Guidance System (PNSGS) is an FDA 510(k)-cleared medical device (K202184) manufactured by Practical Navigation, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 23, 2021. Regulation: 8.