TRIAL 77307478 DIVERGE 0 DEG 7-8X17X14


Product Overview

TRIAL 77307478 DIVERGE 0 DEG 7
DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM - 77307478


Device Description

A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


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


    Code: KWQ

    Device Name: Appliance, Fixation, Spinal Intervertebral Body

    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


    Device Identifiers

    Device Id: 00763000878146

    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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