ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System

ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System is an FDA 510(k)-cleared medical device (K223301) manufactured by Spinecraft, 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 July 19, 2023. Regulation: 8.