FDA 510(k) Application Details - K241525

Device Classification Name	More FDA Info for this Device
510(K) Number	K241525
Device Name	ExcelsiusXRÖ
Applicant	Globus Medical, Inc. Valley Forge Business Center 2560 General Armistead Ave Audubon, PA 19403 US Other 510(k) Applications for this Company
Contact	Jennifer Antonacci Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2024
Decision Date	07/08/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review