510(k) K252699

CoAptix S System by University of Utah, Department of Orthopaedics — Product Code HWC

K252699 is an FDA 510(k) premarket notification submitted by University of Utah, Department of Orthopaedics for the device "CoAptix S System". The FDA issued a decision of Substantially Equivalent on April 10, 2026. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. University of Utah, Department of Orthopaedics has at least 1 other 510(k) clearance on record.