S-COMP Reform® POCT Navigation Instruments

S-COMP Reform® POCT Navigation Instruments is an FDA 510(k)-cleared medical device (K231229) manufactured by Precision 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 May 24, 2023. Regulation: 8.