SafeOp 3: Neural Informatix System

SafeOp 3: Neural Informatix System is an FDA 510(k)-cleared medical device (K252842) manufactured by Alphatec Spine, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 10, 2026. Regulation: 8.