HAtetracell™-C Titanium Cervical IBF System

HAtetracell™-C Titanium Cervical IBF System is an FDA 510(k)-cleared medical device (K231899) manufactured by Innovasis, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 16, 2023. Regulation: 8.