TETHER 9010007012 0.2MM INSERT ASSEMBLY


Product Overview

TETHER 9010007012 0.2MM INSERT ASSEMBLY
Translace™ Spinal Tethering System - 9010007012


Device Description

A band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Thick
    • Thick


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OWI

    Device Name: Bone Fixation Cerclage, Sublaminar

    Device Class: 2

    Physical State: metallic wire, polyester bands

    Definition: Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.

    Submission Type ID: 1

    Review Panel: OR

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Wrapped around a portion of the sublaminar, posterior spine for temporary stabilization during spinal fusion procedures. May be used in conjunction with other medical implants made of similar metals whenever wiring" may help secure the attachment of other implants.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: sublaminar, posterior spine

    Regulation Number: 888.3010

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 00763000333386

    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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