510(k) K223362

Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device by 4Web Medical, Inc. — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 2, 2023
Date Received: November 3, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by 4Web Medical, Inc.

K252834 — Sacroiliac Joint Truss System (SJTS) (January 28, 2026)
K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) (December 11, 2025)
K251117 — Cervical Spine Truss System (CSTS) (April 25, 2025)
K240388 — Osteotomy Truss System (OTS) (November 1, 2024)
K233966 — Anterior Spine Truss System-Stand Alone (ASTS-SA) (April 22, 2024)
K230088 — Ankle Truss System (ATS) (March 21, 2024)
K231739 — Cervical Spine Truss System (CSTS) (September 25, 2023)
K221266 — Cervical Spine Truss System (CSTS) Interbody Fusion Device (January 5, 2023)
K221283 — Hammertoe Truss System (HTS) (September 6, 2022)
K220463 — Osteotomy Truss System (OTS) (May 18, 2022)

Other clearances for product code OVE

K260038 — E3D-C Interbody System (February 4, 2026)
K253876 — HEDRON Cervical Spacers (HEDRON C-MIS Spacer) (December 22, 2025)
K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) (December 11, 2025)
K250076 — Endeavor Stand-Alone Cervical IBF System (September 25, 2025)
K250540 — SABER-C System (August 8, 2025)
K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs) (July 30, 2025)
K251431 — FIX-C PEEK ACIF SA System (June 27, 2025)
K251117 — Cervical Spine Truss System (CSTS) (April 25, 2025)
K242928 — Tesera-k SC System (April 10, 2025)
K243188 — CYLOX® ST (February 11, 2025)