510(k) K243988

RootMend MRR by Riverpoint Medical, LLC — Product Code MBI

K243988 is an FDA 510(k) premarket notification submitted by Riverpoint Medical, LLC for the device "RootMend MRR". The FDA issued a decision of Substantially Equivalent on March 20, 2025. 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.