FDA 510(k) Application Details - K242569

Device Classification Name	More FDA Info for this Device
510(K) Number	K242569
Device Name	Mixed Reality Spine Navigation
Applicant	Brainlab AG Olof-Palme-Str.9 Munich 81829 DE Other 510(k) Applications for this Company
Contact	Esther Moreno Garcia 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	08/28/2024
Decision Date	05/16/2025
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