FDA 510(k) Application Details - K232148

Device Classification Name	More FDA Info for this Device
510(K) Number	K232148
Device Name	X-Guide Surgical Navigation System
Applicant	X-Nav Technologies, LLC 1555 Bustard Road Suite 75 Lansdale, PA 19446 US Other 510(k) Applications for this Company
Contact	Kimberly Chan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2023
Decision Date	02/21/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review