SCREW 7975520 SOVEREIGN FA 5.5 X 20MM


Product Overview

SCREW 7975520 SOVEREIGN FA 5.5 X 20MM
SOVEREIGN™ Spinal System - 7975520


Device Description

A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.


Environmental Conditions

No Data Available


Device Sizes

  • Outer Diameter: 5.5 Millimeter
  • Length: 20.0 Millimeter
    • Outer Diameter: 5.5 Millimeter
    • Length: 20.0 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: 00613994736611

    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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