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Verte-Stack Spinal System

by Medtronic Sofamor Danek, Inc.

510(k) K021791

Active United States. Also listed in GUDID (US).

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), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00721902379550 UDI-DIDate30 Jul 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK021791 Date26 Aug 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  • Withdrawn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) · GUDID

Generic Name
Vertebral body prosthesis
Model / Reference
8915412
FDA applicant
Medtronic Sofamor Danek
Primary DI / UDI-DI
00721902379550
510(k) Number
FDA Product Code
MQP
GMDN Term
Vertebral body prosthesis
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Overview

AI-generated summary, 22 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 spinal prosthesis designed to provide structural support to the vertebral column. It is typically used in conjunction with supplemental spinal fixation and bone graft, and certain models allow for in situ adjustment of prosthesis height to facilitate intraoperative distraction of adjacent vertebrae.

This system must be used with additional anterior or posterior spinal instrumentation, such as the Zplate II Anterior Fixation System, Dynalok Classic Spinal System, or other specified Medtronic Sofamor Danek spinal systems. The device is authorized under FDA 510(k) clearance K021791.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Questions

AI-generated answers, 22 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 Verte-Stack Spinal System?

    The Verte-Stack Spinal System is a spinal prosthesis engineered to provide structural support to the vertebral column. It is intended to be used in conjunction with bone graft and supplemental spinal fixation systems to assist in stabilizing the spine.

  • Can the Verte-Stack Spinal System be used as a standalone device?

    No, this system must be used in combination with additional anterior or posterior spinal instrumentation. It is designed to work alongside specific Medtronic Sofamor Danek systems, such as the Zplate II Anterior Fixation System or the Dynalok Classic Spinal System, to ensure proper stability.

  • Does the system allow for height adjustments during surgery?

    Yes, certain models within the Verte-Stack Spinal System allow for in situ adjustment of the prosthesis height. This feature is designed to facilitate intraoperative distraction of adjacent vertebrae during the surgical procedure.

  • What is the regulatory status of this spinal prosthesis?

    The Verte-Stack Spinal System is authorized under FDA 510(k) clearance K021791, which was granted on August 26, 2002. This indicates the device has been found substantially equivalent to legally marketed predicate devices.

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (9)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No