510(k) K233919

VariAx 2 Distal Radius System by Stryker GmbH — Product Code HRS

K233919 is an FDA 510(k) premarket notification submitted by Stryker GmbH for the device "VariAx 2 Distal Radius System". The FDA issued a decision of Substantially Equivalent on March 25, 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.