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Lateral VBR System

by Nu Vasive, Incorporated

510(k) K140563

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 NumberK140563 Date7 Aug 2014ClearedStatusActive

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  • Withdrawn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
MQP
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 Lateral VBR System is an orthopedic device designed for spinal fusion procedures. It provides structural support and stabilization for the spine during surgery.

The system is supplied as a sterile, single-use device and is available in various sizes. It is intended for use in surgical settings and has received FDA 510(k) clearance with the product code MQP.

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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 Lateral VBR System used for?

    The Lateral VBR System is an orthopedic device designed for spinal fusion procedures. It provides structural support and stabilization for the spine during surgery to help promote proper healing and alignment.

  • How is the Lateral VBR System supplied?

    The system is supplied as a sterile, single-use device and is available in various sizes to accommodate different patient anatomies and surgical requirements. It is intended for use in surgical settings only.

  • What regulatory approval does the Lateral VBR System have?

    The Lateral VBR System has received FDA 510(k) clearance with the product code MQP. It was determined to be substantially equivalent to predicate devices through the traditional clearance process.

  • Can the Lateral VBR System be reused?

    No, the Lateral VBR System is designed as a single-use device only. It should not be reused on multiple patients as this could compromise sterility and device performance, potentially leading to surgical complications.