BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CoFix System

    Reg #: 3005426761 · FEI: 3005426761 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Paradigm Spine GmbH
    Registration Number
    3005426761
    FEI Number
    3005426761
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Eisenbahnstrabe 84
    City
    Wurmlingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K201704

    Owner / Operator

    Firm Name
    Xtant Medical Holdings, Inc.
    Operator Number
    10028385
    Address
    664 Cruiser Lane
    City
    Belgrade
    State
    MT
    Postal Code
    59714
    Country
    US
    Correspondent
    Rebecca Lennemann

    US Agent

    Business Name
    Xtant Medical Holdings, Inc.
    Contact Name
    Rebecca Lennemann
    Address
    664 Cruiser Lane
    City
    Belgrade
    State
    MT
    ZIP
    59714
    Country
    US
    Email
    [email protected]
    Phone
    406 9245878

    Products

    Device Name Product Code
    Spinous Process Plate PEK

    Proprietary Names

    CoFix System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility