SELF DRILLING SCREW


Product Overview

SELF DRILLING SCREW
ESCALATE - 48570210


Device Description

A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).


Environmental Conditions

No Data Available


Device Sizes

  • Length: 10.0 Millimeter
  • Diameter: 2.0 Millimeter
    • Length: 10.0 Millimeter
    • Diameter: 2.0 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: NQW

    Device Name: Orthosis, Spine, Plate, Laminoplasty, Metal

    Device Class: 2

    Physical State: N/A

    Definition: This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.

    Submission Type ID: 1

    Review Panel: OR

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: 888.3050

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 07613252464174

    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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