FDA 510(k) Application Details - K230927

Device Classification Name	More FDA Info for this Device
510(K) Number	K230927
Device Name	OptiMesh Multiplanar Expandable Interbody Fusion System
Applicant	Spineology Inc. 7800 3rd Street North Suite 600 Saint Paul, MN 55128 US Other 510(k) Applications for this Company
Contact	Andrew Adams Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OQB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2023
Decision Date	11/01/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review