510(k) K220723

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

K220723 is an FDA 510(k) premarket notification submitted by Skeletal Dynamics, Inc. for the device "Hand Trauma Screw System". The FDA issued a decision of Substantially Equivalent on May 12, 2022. 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.