510(k) K254306

Aevumed FENIX Suture Anchor by Aevumed, Inc. — Product Code MBI

K254306 is an FDA 510(k) premarket notification submitted by Aevumed, Inc. for the device "Aevumed FENIX Suture Anchor". The FDA issued a decision of Substantially Equivalent on March 4, 2026. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Aevumed, Inc. has at least 7 other 510(k) clearances on record.