510(k) K241864

Grappler Interference Screw System by Paragon 28, Inc. — Product Code MBI

K241864 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "Grappler Interference Screw System". The FDA issued a decision of Substantially Equivalent on July 25, 2024. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Paragon 28, Inc. has at least 10 other 510(k) clearances on record.