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Verte-Stack Spinal System, Extra Small Sizes

by Medtronic Sofamor Danek, Inc.

510(k) K030736

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 NumberK030736 Date2 Apr 2003ClearedStatusActive

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  • Withdrawn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, 28 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 Verte-Stack Spinal System is a stackable corpectomy device made of PEEK material. It is designed to be used with additional anterior and/or posterior spinal instrumentation to augment stability in spinal procedures.

The device must be used with titanium Medtronic Sofamor Danek spinal systems including the ZPLATE II Anterior Fixation System, DYNALOK CLASSIC Spinal System, VANTAGE Anterior Fixation System, TSRH Spinal System, CD HORIZON Spinal System, or their successors. The Verte-Stack Spinal System, Extra Small Sizes is authorized under FDA 510(k) clearance with number K030736.

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Questions

AI-generated answers, 28 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 Verte-Stack Spinal System Extra Small used for?

    The Verte-Stack Spinal System Extra Small is a stackable corpectomy device made of PEEK material designed to augment stability in spinal procedures when used with additional anterior and/or posterior spinal instrumentation systems.

  • Which spinal instrumentation systems are compatible with the Verte-Stack Spinal System?

    The Verte-Stack Spinal System must be used with titanium Medtronic Sofamor Danek spinal systems including the ZPLATE II Anterior Fixation System, DYNALOK CLASSIC Spinal System, VANTAGE Anterior Fixation System, TSRH Spinal System, CD HORIZON Spinal System, or their successors.

  • What is the regulatory status of the Verte-Stack Spinal System Extra Small?

    The Verte-Stack Spinal System Extra Small is authorized under FDA 510(k) clearance with number K030736, which was received on March 10, 2003, and decided on April 2, 2003, with a decision code of SESE indicating substantial equivalence.

  • What material is the Verte-Stack Spinal System Extra Small made from?

    The Verte-Stack Spinal System Extra Small is made of PEEK (polyetheretherketone) material, which is a biocompatible polymer commonly used in medical implants for its strength and radiolucency properties.