Skip to content

LATERAL Spine Truss System

by 4WEB Inc.

510(k) K153436

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK153436 Date6 Jun 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MAX
FDA applicant
4Web, Inc.
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Lateral Spine Truss System is an interbody fusion device designed for spinal stabilization. It employs a truss implant technology with an open architecture to support anterior spinal fusion, providing structural integrity while facilitating bone growth between vertebrae. The device incorporates a proprietary design to distribute mechanical loads and promote a mechanobiologic response in adjacent tissues. Available in multiple configurations, it is intended for use in spinal surgeries requiring lateral access.

This system is supplied as a reusable surgical implant, available in various footprints, lordotic angles, and heights to match patient anatomy. It is intended for use in sterile operating room environments and requires proper handling and sterilization procedures as per surgical protocols. The device has received FDA 510(k) clearance under the Traditional pathway, classified under the Orthopedic advisory committee and product code MAX. No specific MRI safety information is provided in the available data.

Other devices from 4WEB Inc.

See all devices from 4WEB Inc. →