510(k) K243697

MySpine WebPlanner by Medacta International S.A. — Product Code LLZ

K243697 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "MySpine WebPlanner". The FDA issued a decision of Substantially Equivalent on April 23, 2025. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Medacta International S.A. has at least 10 other 510(k) clearances on record.