BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    3D SYSTEMS - LAYERWISE

    Reg #: 3010705004 · FEI: 3010705004 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    3D SYSTEMS - LAYERWISE
    Registration Number
    3010705004
    FEI Number
    3010705004
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Grauwmeer 14
    City
    Heverlee Vlaams Brabant
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K202032

    Owner / Operator

    Firm Name
    LayerWise nv
    Operator Number
    10048431
    Address
    Grauwmeer 14
    City
    Heverlee
    State
    Vlaams Brabant
    Postal Code
    3001
    Country
    BE
    Correspondent
    Benjamin Johnson

    US Agent

    Business Name
    3D Systems - Medical Modeling
    Contact Name
    Benjamin Johnson
    Address
    5381 S Alkire Circle
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 6431001

    Products

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

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)