SOLACE Sacroiliac Fixation System

SOLACE Sacroiliac Fixation System is an FDA 510(k)-cleared medical device (K233241) manufactured by Ht Medical, LLC Dba 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 October 26, 2023. Regulation: 8.