FDA 510(k) Application Details - K250623

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K250623
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	OrthoPediatrics Corp. 2850 Frontier Dr. Warsaw, IN 46582 US Other 510(k) Applications for this Company
Contact	Yan Li Other 510(k) Applications for this Contact
Regulation Number	888.3020   More FDA Info for this Regulation Number
Classification Product Code	HSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/2025
Decision Date	04/01/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review