Skip to content

Modification to Verte-Stack Spinal System

by Medtronic Sofamor Danek, Inc. 9 variants

510(k) K023570

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 · Special NumberK023570 Date19 Nov 2002ClearedStatusActive

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  • Withdrawn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
FDA applicant
Medtronic Sofamor Danek
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

This device is a modification to the Verte-Stack Spinal System, a spinal fixation system used in orthopedic procedures. It is designed to be used with various anterior fixation systems including the ZPLATE II, DYNALOK™ CLASSIC, VANTAGE™, TSRH®, CD HORIZON®, and GDLH® Spinal Systems, or their successors.

The device was cleared via the FDA 510(k) pathway under K023570, with a decision date of November 19, 2002, and is classified as substantially equivalent. It is manufactured by Medtronic Sofamor Danek, Inc. and is intended for use in spinal fixation procedures as part of a broader spinal system.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Questions

AI-generated answers, 26 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 Modification to Verte-Stack Spinal System used for?

    This device is a modification to the Verte-Stack Spinal System and is intended for use in spinal fixation procedures as part of a broader spinal system. It is designed to be used with various anterior fixation systems including the ZPLATE II, DYNALOK™ CLASSIC, VANTAGE™, TSRH®, CD HORIZON®, and GDLH® Spinal Systems, or their successors, to provide stability during orthopedic spinal surgeries.

  • How is the Modification to Verte-Stack Spinal System supplied or packaged?

    The device data does not specify how the Modification to Verte-Stack Spinal System is supplied, packaged, or whether it is sterile or single-use. Therefore, details about its physical form, packaging, sterility, or reusability cannot be determined from the provided information and should be obtained from the manufacturer's labeling or instructions for use.

  • What regulatory pathway was used for the Modification to Verte-Stack Spinal System?

    The device was cleared via the FDA 510(k) pathway under submission number K023570, with a decision date of November 19, 2002. It was classified as substantially equivalent to a predicate device, meaning it demonstrated similar safety and effectiveness to a legally marketed device through the 510(k) submission process.