Product Overview

Locking Plate
ENDOSKELETON® TCS Sterile Barrier System - 5303-1405-S


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

  • Compatible with all ENDOSKELETON® TCS interbody fusion devices
    • Compatible with all ENDOSKELETON® TCS interbody fusion devices


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OVE

    Device Name: Intervertebral Fusion Device With Integrated Fixation, Cervical

    Device Class: 2

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

    Definition: Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

    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; also includes some form of integrated fixation to maintain stability by direct purchase into the bony vertebral endplates.

    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: 00191375039976

    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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