510(k) K243963

Pediatric Plating Platform Hip by OrthoPediatrics Corp. — Product Code HRS

K243963 is an FDA 510(k) premarket notification submitted by OrthoPediatrics Corp. for the device "Pediatric Plating Platform Hip". The FDA issued a decision of Substantially Equivalent on April 29, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. OrthoPediatrics Corp. has at least 10 other 510(k) clearances on record.