510(k) K241695

Extremity All Suture System by Field Orthopaedics — Product Code MBI

K241695 is an FDA 510(k) premarket notification submitted by Field Orthopaedics for the device "Extremity All Suture System". The FDA issued a decision of Substantially Equivalent on September 12, 2024. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040.