510(k) K200538

Skeletal Dynamics Forearm Plating System by Skeletal Dynamics, Inc. — Product Code HRS

K200538 is an FDA 510(k) premarket notification submitted by Skeletal Dynamics, Inc. for the device "Skeletal Dynamics Forearm Plating System". The FDA issued a decision of Substantially Equivalent on June 1, 2020. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Skeletal Dynamics, Inc. has at least 10 other 510(k) clearances on record.