1,2MM DYNAMIC MESH-STD-X-LARGE


Product Overview

1,2MM DYNAMIC MESH
NA - 56-90628


Device Description

A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be included with the plate.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 200.0 Millimeter
  • Width: 200.0 Millimeter
  • Thickness: 0.6 Millimeter
    • Length: 200.0 Millimeter
    • Width: 200.0 Millimeter
    • Thickness: 0.6 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: GWO

    Device Name: Plate, Cranioplasty, Preformed, Alterable

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: NE

    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: 882.5320

    Third Party Flag: N

    Medical Specialty: NE


    Device Identifiers

    Device Id: 07613327123128

    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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