510(k) K260321

HipGuide (V 1.0.0.0) by Orthopedic Driven Imaging, LLC — Product Code LLZ

K260321 is an FDA 510(k) premarket notification submitted by Orthopedic Driven Imaging, LLC for the device "HipGuide (V 1.0.0.0)". The FDA issued a decision of Substantially Equivalent on May 8, 2026. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.