510(k) K260921

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line by Tigon Medical — Product Code MBI

K260921 is an FDA 510(k) premarket notification submitted by Tigon Medical for the device "Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line". The FDA issued a decision of Substantially Equivalent on April 21, 2026. 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.