FDA 510(k) Application Details - K251117

Device Classification Name	More FDA Info for this Device
510(K) Number	K251117
Device Name	Cervical Spine Truss System (CSTS)
Applicant	4WEB Medical 2801 Network Blvd., Suite 620 Frisco, TX 75034 US Other 510(k) Applications for this Company
Contact	Jonathan Hires Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2025
Decision Date	04/25/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review