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VERTEX® Reconstruction System X1211107

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Overview

The VERTEX Reconstruction System is a non-bioabsorbable spinal bone screw designed for internal spinal fixation in the treatment of spinal instabilities or deformities. Featuring a threaded implant with a screw head and drive, it provides immobilization and stabilization of spinal segments by being screwed into the spine to hold a correction/stabilization device.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169115149 UDI-DI Date21 Jul 2015ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1826-2016 FDA Class II initiated 1 Apr 2016

    Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
VERTEX® Reconstruction System
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Reference
X1211107
Primary DI / UDI-DI
00643169115149
510(k) Number
FDA Product Code
KWP
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3050
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K083071)

Show all (12)

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Properties

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

Other properties (10)

  • Sterile: No
  • 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