510(k) K231231

MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices by Paragon 28, Inc. — Product Code HWC

K231231 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices". The FDA issued a decision of Substantially Equivalent on October 12, 2023. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Paragon 28, Inc. has at least 10 other 510(k) clearances on record.