510(k) K261770

Suture Button Repair System by Skeletal Dynamics, Inc. — Product Code MBI

K261770 is an FDA 510(k) premarket notification submitted by Skeletal Dynamics, Inc. for the device "Suture Button Repair System". The FDA issued a decision of Substantially Equivalent on July 29, 2026. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Skeletal Dynamics, Inc. has at least 10 other 510(k) clearances on record.