510(k) K232144

Sterile Products of the APTUS System by Medartis AG — Product Code HRS

K232144 is an FDA 510(k) premarket notification submitted by Medartis AG for the device "Sterile Products of the APTUS System". The FDA issued a decision of Substantially Equivalent on August 18, 2023. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Medartis AG has at least 10 other 510(k) clearances on record.