SCREW 9000260 SI TI CANN 12X60


Product Overview

SCREW 9000260 SI TI CANN 12X60
RIALTO™ SI FUSION SYSTEM - 9000260


Device Description

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.


Environmental Conditions

No Data Available


Device Sizes

  • 12mm x 60mm
    • 12mm x 60mm


    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: OUR

    Device Name: Sacroiliac Joint Fixation

    Device Class: 2

    Physical State: may be used with bone graft, should not be used with bone cement

    Definition: sacroiliac joint fusion

    Submission Type ID: 1

    Review Panel: OR

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: bridges both sides of the joint, preventing motion

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: sacroiliac joint

    Regulation Number: 888.3040

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 00643169273849

    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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