510(k) K243835

TiLink-P SI Joint Fusion System by SurGenTec, LLC — Product Code OUR

K243835 is an FDA 510(k) premarket notification submitted by SurGenTec, LLC for the device "TiLink-P SI Joint Fusion System". The FDA issued a decision of Substantially Equivalent on December 27, 2024. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. SurGenTec, LLC has at least 10 other 510(k) clearances on record.