Infinity™ OCT System, PASS OCT® Spinal System

Infinity™ OCT System, PASS OCT® Spinal System is an FDA 510(k)-cleared medical device (K210449) manufactured by Medtronic. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 17, 2021. Regulation: 8.