Matrix HA PEEK Cervical Implant System

Matrix HA PEEK Cervical Implant System is an FDA 510(k)-cleared medical device (K192316) manufactured by Sapphire Medical Group. 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, 2019. Regulation: 8.