510(k) K251933

SnugFit ASA Extension by Medacta International S.A. — Product Code MBI

K251933 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "SnugFit ASA Extension". The FDA issued a decision of Substantially Equivalent on July 1, 2025. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Medacta International S.A. has at least 10 other 510(k) clearances on record.