OPTIX H2 Patient Specific Instrument System

OPTIX H2 Patient Specific Instrument System is an FDA 510(k)-cleared medical device (K230462) manufactured by Vilex, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 16, 2023. Regulation: 8.