510(k) K232251

APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension by Medartis AG — Product Code HWC

K232251 is an FDA 510(k) premarket notification submitted by Medartis AG for the device "APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension". The FDA issued a decision of Substantially Equivalent on November 3, 2023. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Medartis AG has at least 10 other 510(k) clearances on record.