FDA 510(k) Application Details - K242356

Device Classification Name	More FDA Info for this Device
510(K) Number	K242356
Device Name	TIDAL Fusion Cage System
Applicant	restor3d, Inc. 4001 NC-54 Hwy, Suite 3160 Durham, NC 27709 US Other 510(k) Applications for this Company
Contact	Brianna Prindle Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2024
Decision Date	03/24/2025
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