510(k) K231649

Intraosseous Fusion Device System by Auxano Medical, LLC — Product Code HWC

K231649 is an FDA 510(k) premarket notification submitted by Auxano Medical, LLC for the device "Intraosseous Fusion Device System". The FDA issued a decision of Substantially Equivalent on September 29, 2023. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Auxano Medical, LLC has at least 1 other 510(k) clearance on record.