510(k) K221088

Anatomic Bone Plate by Double Medical Technology, Inc. — Product Code HRS

K221088 is an FDA 510(k) premarket notification submitted by Double Medical Technology, Inc. for the device "Anatomic Bone Plate". The FDA issued a decision of Substantially Equivalent on January 18, 2023. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Double Medical Technology, Inc. has at least 10 other 510(k) clearances on record.