SafeOp 2: Neural Informatix System

SafeOp 2: Neural Informatix System is an FDA 510(k)-cleared medical device (K213849) 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 March 8, 2022. Regulation: 8.