510(k) K242529

Tigon Medical All-Suture Anchors (ASA) by Tigon Medical — Product Code MBI

K242529 is an FDA 510(k) premarket notification submitted by Tigon Medical for the device "Tigon Medical All-Suture Anchors (ASA)". The FDA issued a decision of Substantially Equivalent on December 20, 2024. 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.