Vantage Anterior Fixation System

No FDA recalls found in the data synced 22 Oct 2026.

Generic name

Metallic spinal interbody fusion cage

Model / reference

9338045

Primary DI / UDI-DI

00885074338590

510(k) Number

K031533 ↗

FDA product code

KWP

GMDN term

Metallic spinal interbody fusion cage

Device class

Class II

Regulation

21 CFR Part 888.3050

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Size

Length — 45.0 Millimeter

Outer Diameter — 8.0 Millimeter

• MSB Reusable Instruments 9870005

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• MSB CD HORIZON Spinal System 6530530

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  FDA 510(k) K183510 Active Cleared 16 Jan 2019 GUDID on market

• MSB SHILLA Growth Guidance System 7670431

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  FDA 510(k) K140750 Active Cleared 17 Jul 2014 GUDID on market

• MSB Reusable Instruments 7967011

  Class I

  GUDID on market

• Medtronic Reusable Instruments X3690250

  Class I

  GUDID on market

See all devices from Medtronic Sofamor Danek, Inc. →

• What is the Vantage Anterior Fixation System used for?

  The Vantage Anterior Fixation System is designed to provide immobilization and support to spinal segments during fusion procedures in the thoracic, lumbar, and sacral regions. It acts as an adjunct to spinal alignment surgeries, helping maintain structural integrity and stability where surgical intervention is required.

• How is the Vantage Anterior Fixation System supplied?

  This system is supplied as a sterile, single-use device, ensuring it meets surgical standards for cleanliness and safety. Each component, including bolts and plates, is intended for one-time use in controlled surgical environments to prevent contamination and maintain efficacy.

• Are the components of the Vantage Anterior Fixation System reusable?

  No, the Vantage Anterior Fixation System is explicitly designed for single-use only. Reusing medical devices like this can compromise sterility and integrity, increasing the risk of infection or mechanical failure during surgery.

• What reference codes identify specific components of the system?

  The system includes components with distinct reference codes, such as the 9338050 (8.0×50mm Bolt) and 9331060 (6cm Thoracic Plate). These codes help clinicians select the appropriate size and type of hardware for their surgical needs.

• How should the Vantage Anterior Fixation System be stored?

  Storage must comply with sterile medical device protocols to preserve the system’s integrity before use. This includes maintaining sealed packaging, protecting from physical damage, and adhering to manufacturer guidelines to ensure sterility and functionality.