FDA 510(k) Application Details - K233966

Device Classification Name	More FDA Info for this Device
510(K) Number	K233966
Device Name	Anterior Spine Truss System-Stand Alone (ASTS-SA)
Applicant	4WEB Medical, Inc. 2801 Network Drive Suite 620 Frisco, TX 75034 US Other 510(k) Applications for this Company
Contact	Richard Jansen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2023
Decision Date	04/22/2024
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