FDA 510(k) Application Details - K243623

Device Classification Name	More FDA Info for this Device
510(K) Number	K243623
Device Name	SpineAR SNAP (SyncAR Spine)
Applicant	Surgical Theater, Inc. 23645 Mercantile Road Suite M Beachwood, OH 44122 US Other 510(k) Applications for this Company
Contact	Kevin Murrock 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	11/25/2024
Decision Date	12/24/2024
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