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Spinal USA VBR System

by Spinal USA

510(k) K070922

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 NumberK070922 Date19 Sep 2007ClearedStatusActive

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  • Withdrawn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)

Full name
Modification to Spinal USA Vbr System
510(k) Number
FDA Product Code
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Spinal USA VBR System is a spinal intervertebral body fixation appliance designed to replace diseased or fractured vertebral bodies in the thoracolumbar spine. It functions to restore vertebral height and the biomechanical integrity of the spinal column.

This device is identified by FDA 510(k) number K070922 and is classified as a Class 2 medical device. It is intended for use as a supplemental fixation device via lateral or anterolateral surgical approaches.

Other devices from Spinal USA, LLC

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Questions

AI-generated answers, 23 Sep 2026

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

  • What is the primary function of the Spinal USA VBR System?

    This device is designed to replace diseased or fractured vertebral bodies within the thoracolumbar spine. Its primary function is to restore vertebral height and maintain the biomechanical integrity of the spinal column.

  • What surgical approaches are used with this fixation device?

    The system is intended for use as a supplemental fixation device specifically via lateral or anterolateral surgical approaches to the spine.

  • What is the regulatory status of this device?

    The Spinal USA VBR System is classified as a Class 2 medical device and was cleared via the FDA 510(k) process under number K070922, where it was determined to be substantially equivalent to existing devices.