FDA 510(k) Application Details - K231739

Device Classification Name

  More FDA Info for this Device
510(K) Number K231739
Device Name Cervical Spine Truss System (CSTS)
Applicant 4Web Medical, Inc.
2801 Network Blvd.
Suite 620
Frisco, TX 75034 US
Other 510(k) Applications for this Company
Contact Lewis Harrison
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 06/14/2023
Decision Date 09/25/2023
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact