BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stimulator, Invasive Bone Growth

    PMA: P790005 · Supplement: S058 · Decision Mar 14, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Stimulator, Invasive Bone Growth
    Trade Name
    EBI OsteoGen Implantable Bone Growth Stimulators
    PMA Number
    P790005
    Supplement Number
    S058
    Device Class
    FDA Class 3
    Product Code
    LOE
    Generic Name
    Stimulator, invasive bone growth
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 14, 2018
    Date Received
    February 21, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of an alternate supplier to provide clean room contract certification services and High Efficiency Particulate Air (HEPA) filter distribution services for both the SpF Implantable Spinal Fusion System and the EBI OsteoGen Implantable Bone Growth Stimulator.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOE Stimulator, Invasive Bone Growth