510(k) K251382

Phoenix Sinus Tarsi Stent System by Astra Orthomed, Inc. — Product Code HWC

K251382 is an FDA 510(k) premarket notification submitted by Astra Orthomed, Inc. for the device "Phoenix Sinus Tarsi Stent System". The FDA issued a decision of Substantially Equivalent on August 27, 2025. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040.