510(k) K252635

ArthroTAK Tendon Anchor Kit by ArthroTAK, LLC — Product Code MBI

K252635 is an FDA 510(k) premarket notification submitted by ArthroTAK, LLC for the device "ArthroTAK Tendon Anchor Kit". The FDA issued a decision of Substantially Equivalent on May 1, 2026. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040.