BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Skyway Anterior Cervical Plate System

    Reg #: 3015398319 · FEI: 3007932279 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Kyocera Medical Technologies, Inc.
    Registration Number
    3015398319
    FEI Number
    3007932279
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1289 Bryn Mawr Ave Ste A
    City
    Redlands
    State
    CA
    ZIP
    92374
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243015

    Owner / Operator

    Firm Name
    Kyocera Medical Technologies, Inc.
    Operator Number
    10030880
    Address
    1289 Bryn Mawr Avenue, Suite A
    City
    Redlands
    State
    CA
    Postal Code
    92374
    Country
    US
    Correspondent
    Anthony DeBenedictis

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE

    Proprietary Names

    Skyway Anterior Cervical Plate System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198