510(k) K242445

Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System by Stryker GmbH — Product Code HRS

K242445 is an FDA 510(k) premarket notification submitted by Stryker GmbH for the device "Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System". The FDA issued a decision of Substantially Equivalent on October 6, 2024. 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.