FDA 510(k) Application Details - K242270

Device Classification Name	More FDA Info for this Device
510(K) Number	K242270
Device Name	OrthoNext Platform System
Applicant	Orthofix Srl Via delle Nazioni, 9 Bussolengo 37012 IT Other 510(k) Applications for this Company
Contact	Elvira Taccarelli Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2024
Decision Date	12/19/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review