BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Elatus Lumbar Plate System

    Reg #: 3009790163 · FEI: 3009790163 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    AEGIS SPINE
    Registration Number
    3009790163
    FEI Number
    3009790163
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    130 McCormick Ave, Suite 106
    City
    Costa Mesa
    State
    CA
    ZIP
    92626
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221050

    Owner / Operator

    Firm Name
    Aegis Spine
    Operator Number
    10031416
    Address
    130 McCormick Ave, Suite 106
    City
    Costa Mesa
    State
    CA
    Postal Code
    92626
    Country
    US
    Correspondent
    Tony Ahn

    Products

    Device Name Product Code
    Sacroiliac Joint Fixation OUR
    Posterior Cervical Screw System NKG
    Appliance, Fixation, Spinal Interlaminal KWP
    Appliance, Fixation, Spinal Intervertebral Body KWQ

    Proprietary Names

    Elatus Lumbar Plate System ZESPIN SI Joint Fusion System Paeon Posterior Cervical Fixation System Paeon Anterior Cervical Plate System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility