TRIAL 9010002088 TRIAL L 42X30 22MM 24 D


Product Overview

TRIAL 9010002088 TRIAL L 42X30 22MM 24 D
SOVEREIGN™ Spinal System - 9010002088


Device Description

A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 42.0 Millimeter
  • Height: 22.0 Millimeter
  • Width: 30.0 Millimeter
    • Length: 42.0 Millimeter
    • Height: 22.0 Millimeter
    • Width: 30.0 Millimeter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: True

    Sterilization Methods:

  • Moist Heat or Steam Sterilization
    • Moist Heat or Steam Sterilization


    Product Codes

    Code: OVD

    Device Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar

    Device Class: 2

    Physical State: Hollow cylinder or rectangular box made of metal or polymer with integrated fixation.

    Definition: Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

    Submission Type ID: 1

    Review Panel: OR

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Acts as a disc spacer and holds bone graft; also includes some form of integrated fixation to maintain stability by direct purchase into the bony vertebral endplates.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: Intervertebral disc space

    Regulation Number: 888.3080

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 00643169655874

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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