510(k) K230908

Hand Trauma Threaded Nail System by Skeletal Dynamics, Inc. — Product Code HWC

K230908 is an FDA 510(k) premarket notification submitted by Skeletal Dynamics, Inc. for the device "Hand Trauma Threaded Nail System". The FDA issued a decision of Substantially Equivalent on April 28, 2023. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Skeletal Dynamics, Inc. has at least 10 other 510(k) clearances on record.