90-Degree Retractor, 11mm

Product Overview

Kyocera Medical Technologies, Inc. - S 141

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 in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical 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 included with the 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: MAX

    Device Name: Intervertebral Fusion Device With Bone Graft, Lumbar

    Device Class: 2

    Physical State: hollow cylinder or rectangular box made of metal or polymer

    Definition: Intended to stabilize 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: 00841523123629

    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

    Educational Resources