510(k) K231162

ROSA Hip System by Orthosoft Inc (D/B/A Zimmer Cas) — Product Code LLZ

K231162 is an FDA 510(k) premarket notification submitted by Orthosoft Inc (D/B/A Zimmer Cas) for the device "ROSA Hip System". The FDA issued a decision of Substantially Equivalent on May 23, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Orthosoft Inc (D/B/A Zimmer Cas) has at least 10 other 510(k) clearances on record.