Gemini-C Hybrid Cervical Interbody System

Gemini-C Hybrid Cervical Interbody System is an FDA 510(k)-cleared medical device (K170844) manufactured by Osseus Fusion Systems, 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 2, 2017. Regulation: 8.