510(k) K231831

TiLink-L Joint Fusion System by Surgentec — Product Code OUR

K231831 is an FDA 510(k) premarket notification submitted by Surgentec for the device "TiLink-L Joint Fusion System". The FDA issued a decision of Substantially Equivalent on August 3, 2023. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Surgentec has at least 10 other 510(k) clearances on record.