510(k) K192323

PolyLock Small Bone Plating System by Fusion Orthopedics, LLC — Product Code HRS

K192323 is an FDA 510(k) premarket notification submitted by Fusion Orthopedics, LLC for the device "PolyLock Small Bone Plating System". The FDA issued a decision of Substantially Equivalent on November 18, 2019. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Fusion Orthopedics, LLC has at least 10 other 510(k) clearances on record.