FDA 510(k) Application Details - K172583

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K172583
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	OrthoPediatrics, Inc. 2850 Frontier Drive Warsaw, IN 46582 US Other 510(k) Applications for this Company
Contact	Adam Cargill 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	08/28/2017
Decision Date	05/10/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review