510(k) K211429

NAVIPLAN - CT Planning Software for Total Hip Replacement by Naviswiss AG — Product Code LLZ

K211429 is an FDA 510(k) premarket notification submitted by Naviswiss AG for the device "NAVIPLAN - CT Planning Software for Total Hip Replacement". The FDA issued a decision of Substantially Equivalent on Oct 5, 2021. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Naviswiss AG has 2 other 510(k) clearances on record.