SafeOp 3: Neural Informatix Systeem

SafeOp 3: Neural Informatix Systeem is an FDA 510(k)-cleared medical device (K234092) 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 April 18, 2024. Regulation: 8.