510(k) K202589

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

K202589 is an FDA 510(k) premarket notification submitted by Medartis AG for the device "APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System". The FDA issued a decision of Substantially Equivalent on November 6, 2020. 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.