510(k) K261121

Megalodon Dynamic Compression System by Paragon 28, Inc. — Product Code JDR

K261121 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "Megalodon Dynamic Compression System". The FDA issued a decision of Substantially Equivalent on August 6, 2026. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Paragon 28, Inc. has at least 10 other 510(k) clearances on record.