BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Invasive Bone Growth

    PMA: P850035 · Supplement: S051 · Decision Nov 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Stimulator, Invasive Bone Growth
    Trade Name
    SpF Implantable Spinal Fusion Stimulators
    PMA Number
    P850035
    Supplement Number
    S051
    Device Class
    FDA Class 3
    Product Code
    LOE
    Generic Name
    Stimulator, invasive bone growth
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 2, 2018
    Date Received
    April 2, 2018
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for implementation of an additional finished device cleaning process and associated new, semi- automated, PLC cleaning equipment to further ensure adequate removal of manufacturing materials and residue from finished devices has occurred through conformance to cleanliness requirements in accordance with Zimmer Biomet GES 09802 Implant Residual Materials and Endotoxin Limits.

    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