BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HEDRON Lumbar Spacer

    Reg #: 3010032903 · FEI: 3010032903 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    FIRST ARTICLE INC
    Registration Number
    3010032903
    FEI Number
    3010032903
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    150 S Front St Suite B
    City
    Souderton
    State
    PA
    ZIP
    18964
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191391

    Owner / Operator

    Firm Name
    First Article Inc
    Operator Number
    10042762
    Address
    150 S Front St, Suite B
    City
    Souderton
    State
    PA
    Postal Code
    18964
    Country
    US
    Correspondent
    Bill Green

    Products

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

    Proprietary Names

    HEDRON Lumbar Spacer

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)