510(k) K230744

Acumed Acutrak 3 Headless Compression Screw System by Acumed, LLC — Product Code HWC

K230744 is an FDA 510(k) premarket notification submitted by Acumed, LLC for the device "Acumed Acutrak 3 Headless Compression Screw System". The FDA issued a decision of Substantially Equivalent on June 9, 2023. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Acumed, LLC has at least 10 other 510(k) clearances on record.