510(k) K253695

LigaMend by Riverpoint Medical, LLC — Product Code MBI

K253695 is an FDA 510(k) premarket notification submitted by Riverpoint Medical, LLC for the device "LigaMend". The FDA issued a decision of Substantially Equivalent on February 27, 2026. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Riverpoint Medical, LLC has at least 10 other 510(k) clearances on record.