Infinity™ OCT System

Infinity™ OCT System is an FDA 510(k)-cleared medical device (K253129) manufactured by Medtronic Sofamor Danek USA, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 23, 2025. Regulation: 8.