510(k) K210653

ONE Planner Hip by Orthosoft D/B/A Zimmer Cas — Product Code LLZ

K210653 is an FDA 510(k) premarket notification submitted by Orthosoft D/B/A Zimmer Cas for the device "ONE Planner Hip". The FDA issued a decision of Substantially Equivalent on July 7, 2021. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Orthosoft D/B/A Zimmer Cas has at least 6 other 510(k) clearances on record.