CENTERPIECE 436120C 20MM C-SIZE STERILE


Product Overview

CENTERPIECE 436120C 20MM C
T2 STRATOSPHERE Expandable Corpectomy System - 436120C


Device Description

A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.


Environmental Conditions

No Data Available


Device Sizes

  • Outer Diameter: 20.0 Millimeter
    • Outer Diameter: 20.0 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: MQP

    Device Name: Spinal Vertebral Body Replacement Device

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    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: 888.3060

    Third Party Flag: N

    Medical Specialty: OR


    Code: PLR

    Device Name: Spinal Vertebral Body Replacement Device - Cervical

    Device Class: 2

    Physical State: Metallic or polymeric device (usually rectangular or cylindrical), with open central and lateral canals for bone graft containment, providing rigidity and structural support.

    Definition: Vertebral body replacement in the cervical spine.

    Submission Type ID: 1

    Review Panel: OR

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Provides structural support for the indicated population.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: Cervical spine

    Regulation Number: 888.3060

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 00643169634862

    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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