FDA 510(k) Application Details - K190870

Device Classification Name	More FDA Info for this Device
510(K) Number	K190870
Device Name	Cervical Spinal Truss System-Stand Alone (CSTS-SA)
Applicant	4Web, Inc. 2801 Network Blvd. Suite 620 Frisco, TX 75034 US Other 510(k) Applications for this Company
Contact	Jessee Hunt 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	04/03/2019
Decision Date	08/12/2019
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