CHENA-C Spacer System

CHENA-C Spacer System is an FDA 510(k)-cleared medical device (K213115) manufactured by Kahtnu Surgical, 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 December 5, 2021. Regulation: 8.