510(k) K231262

Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System by Stryker GmbH — Product Code HRS

K231262 is an FDA 510(k) premarket notification submitted by Stryker GmbH for the device "Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System". The FDA issued a decision of Substantially Equivalent on August 18, 2023. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Stryker GmbH has at least 10 other 510(k) clearances on record.