Xenix Medical Sacroiliac Fixation System

Xenix Medical Sacroiliac Fixation System is an FDA 510(k)-cleared medical device (K231829) manufactured by Ht Medical D.B.A. Xenix Medical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 14, 2023. Regulation: 8.