510(k) K231829

Xenix Medical Sacroiliac Fixation System by Ht Medical D.B.A. Xenix Medical — Product Code OUR

K231829 is an FDA 510(k) premarket notification submitted by Ht Medical D.B.A. Xenix Medical for the device "Xenix Medical Sacroiliac Fixation System". The FDA issued a decision of Substantially Equivalent on August 15, 2023. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Ht Medical D.B.A. Xenix Medical has at least 2 other 510(k) clearances on record.