510(k) K254288

Clavicle Fixation System by Skeletal Dynamics, Inc. — Product Code HRS

K254288 is an FDA 510(k) premarket notification submitted by Skeletal Dynamics, Inc. for the device "Clavicle Fixation System". The FDA issued a decision of Substantially Equivalent on March 23, 2026. 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.