FDA 510(k) Application Details - K250255

Device Classification Name	More FDA Info for this Device
510(K) Number	K250255
Device Name	xvision Spine system
Applicant	Augmedics Ltd. 2 Ha-Otsma St. Yokneam Illit 2069205 IL Other 510(k) Applications for this Company
Contact	Tami Harel 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	01/28/2025
Decision Date	03/13/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review