510(k) K230550

JAWS Nitinol Staple System by Paragon 28, Inc. — Product Code JDR

K230550 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "JAWS Nitinol Staple System". The FDA issued a decision of Substantially Equivalent on May 11, 2023. 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.