510(k) K040022

STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM by Stryker Leibinger — Product Code HRS

K040022 is an FDA 510(k) premarket notification submitted by Stryker Leibinger for the device "STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM". The FDA issued a decision of Substantially Equivalent on March 12, 2004. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Stryker Leibinger has at least 10 other 510(k) clearances on record.