510(k) K252758

Cannulated Screw and Kirschner (K wire) System by Orthonovis, Inc. — Product Code HWC

K252758 is an FDA 510(k) premarket notification submitted by Orthonovis, Inc. for the device "Cannulated Screw and Kirschner (K wire) System". The FDA issued a decision of Substantially Equivalent on October 2, 2025. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Orthonovis, Inc. has at least 4 other 510(k) clearances on record.