Tailored-H Cervical Stand Alone System

Tailored-H Cervical Stand Alone System is an FDA 510(k)-cleared medical device (K222903) manufactured by Bespoke Technologies, 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 November 17, 2022. Regulation: 8.