510(k) K252596

Tigon Medical Knotless and Dual Javelin All-Suture Anchors by Tigon Medical — Product Code MBI

K252596 is an FDA 510(k) premarket notification submitted by Tigon Medical for the device "Tigon Medical Knotless and Dual Javelin All-Suture Anchors". The FDA issued a decision of Substantially Equivalent on December 4, 2025. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Tigon Medical has at least 6 other 510(k) clearances on record.