510(k) K211049

Tigon Medical Button System by Tigon Medical — Product Code MBI

K211049 is an FDA 510(k) premarket notification submitted by Tigon Medical for the device "Tigon Medical Button System". The FDA issued a decision of Substantially Equivalent on August 4, 2021. 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.