510(k) K220921

Metal Bone Screw by Double Medical Technology, Inc. — Product Code HWC

K220921 is an FDA 510(k) premarket notification submitted by Double Medical Technology, Inc. for the device "Metal Bone Screw". The FDA issued a decision of Substantially Equivalent on December 12, 2022. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Double Medical Technology, Inc. has at least 10 other 510(k) clearances on record.