FDA 510(k) Application Details - K231944

Device Classification Name	More FDA Info for this Device
510(K) Number	K231944
Device Name	CATAMARAN SI Joint Fusion System
Applicant	Tenon Medical, Inc. 104 Cooper Court Los Gatos, CA 95032 US Other 510(k) Applications for this Company
Contact	Susan Noreiga Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/30/2023
Decision Date	08/24/2023
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