BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DualX

    Reg #: 3015255331 · FEI: 3015255331 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AMPLIFY SURGICAL
    Registration Number
    3015255331
    FEI Number
    3015255331
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    27092 Burbank
    City
    Foothill Ranch
    State
    CA
    ZIP
    92610
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181397

    Owner / Operator

    Firm Name
    amplify surgical
    Operator Number
    10059198
    Address
    27092 Burbank
    City
    Foothill Ranch
    State
    CA
    Postal Code
    92610
    Country
    US
    Correspondent
    clark h hutton

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    DualX

    Establishment Types

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