510(k) K250623

Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur by OrthoPediatrics Corp. — Product Code HSB

K250623 is an FDA 510(k) premarket notification submitted by OrthoPediatrics Corp. for the device "Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur". The FDA issued a decision of Substantially Equivalent on April 1, 2025. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. OrthoPediatrics Corp. has at least 10 other 510(k) clearances on record.