510(k) K211439

Small Bone Nailing System by Skeletal Dynamics, Inc. — Product Code HTY

K211439 is an FDA 510(k) premarket notification submitted by Skeletal Dynamics, Inc. for the device "Small Bone Nailing System". The FDA issued a decision of Substantially Equivalent on September 30, 2021. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Skeletal Dynamics, Inc. has at least 10 other 510(k) clearances on record.