510(k) K163405

360KS Implant Positioning System by Kico Knee Innovation Company Pty Limited — Product Code LLZ

K163405 is an FDA 510(k) premarket notification submitted by Kico Knee Innovation Company Pty Limited for the device "360KS Implant Positioning System". The FDA issued a decision of Substantially Equivalent on March 21, 2017. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Kico Knee Innovation Company Pty Limited has at least 3 other 510(k) clearances on record.