FDA 510(k) Application Details - K241870

Device Classification Name	More FDA Info for this Device
510(K) Number	K241870
Device Name	OnPoint Augmented Reality Spine System
Applicant	OnPoint Surgical, Inc. 555 Virginia Rd Suite 103 Concord, MA 01742 US Other 510(k) Applications for this Company
Contact	Amy O'Donnell 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	06/27/2024
Decision Date	08/19/2024
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