SPACER X0312072 TI PER C XS 7X13X12


Product Overview

SPACER X0312072 TI PER C XS 7X13X12
PERIMETER® C Spinal System - X0312072


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

  • Length: 12.0 Millimeter
  • Height: 7.0 Millimeter
  • Width: 13.0 Millimeter
    • Length: 12.0 Millimeter
    • Height: 7.0 Millimeter
    • Width: 13.0 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: ODP

    Device Name: Intervertebral Fusion Device With Bone Graft, Cervical

    Device Class: 2

    Physical State: Hollow cylinder or rectangular box made of metal or polymer.

    Definition: Intended to stabilize cervical 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: 00643169200616

    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


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos