Kalitec Navigated Instrument System

Kalitec Navigated Instrument System is an FDA 510(k)-cleared medical device (K232572) manufactured by Kalitec Direct, LLC Doing Business AS Kalitec Medical. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 2023. Regulation: 8.