TRIAL 2989260 22MM 12 DEG 12 X 60 DL


Product Overview

TRIAL 2989260 22MM 12 DEG 12 X 60 DL
Clydesdale™ Spinal System - 2989260


Device Description

A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 60.0 Millimeter
  • Outer Diameter: 12.0 Millimeter
  • Angle: 12.0 degree
    • Length: 60.0 Millimeter
    • Outer Diameter: 12.0 Millimeter
    • Angle: 12.0 degree


    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: MAX

    Device Name: Intervertebral Fusion Device With Bone Graft, Lumbar

    Device Class: 2

    Physical State: hollow cylinder or rectangular box made of metal or polymer

    Definition: Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

    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.

    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: 00613994973269

    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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