BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    E3D™-C Interbody System

    Reg #: 3022295665 · FEI: 3022295665 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    AMNOVIS BV
    Registration Number
    3022295665
    FEI Number
    3022295665
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Betekomsesteenweg 47C
    City
    Aarschot Flanders
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K241846

    Owner / Operator

    Firm Name
    Amnovis BV
    Operator Number
    10087492
    Address
    Betekomsesteenweg 47C
    City
    Aarschot
    State
    Flanders
    Postal Code
    3200
    Country
    BE
    Correspondent
    Mindy McCann

    US Agent

    Business Name
    Qserve Group US Inc.
    Contact Name
    Mindy McCann
    Address
    350 S Main Street, Suite 309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Intervertebral Fusion Device With Bone Graft, Cervical ODP

    Proprietary Names

    E3D™-C Interbody System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)