510(k) K241983

Fassier-Duval Telescoping IM System by Orthopediatrics Canada Ulc Dba Pega Medical — Product Code HSB

K241983 is an FDA 510(k) premarket notification submitted by Orthopediatrics Canada Ulc Dba Pega Medical for the device "Fassier-Duval Telescoping IM System". The FDA issued a decision of Substantially Equivalent on February 21, 2025. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020.