BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Spinous Process Spacer/Plate

    PMA: P140004 · Supplement: S015 · Decision Aug 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Prosthesis, Spinous Process Spacer/Plate
    Trade Name
    Superion® Indirect Decompression System
    PMA Number
    P140004
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    NQO
    Generic Name
    Prosthesis, spinous process spacer/plate
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 24, 2018
    Date Received
    June 22, 2018
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval of three (3) manufacturing sites for Structure Medical, LLC, located at: 111 Cayuga Drive, Mooresville, North Carolina, 28117 to manufacture components in versions 1 and 2 (v1.0 and v2.0) of the Superion® implant; 9935 Business Circle, Naples, Florida, 34112 to manufacture components in v1.0 and v2.0 of the Superion® implant, assemby and final inspections of the implants; and, 3511 Plover Avenue, Naples, Florida 34117 for passivation activities of components in v1.0 and v2.0 of the Superion® implant.

    Classifications

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

    Product Code Device Name
    NQO Prosthesis, Spinous Process Spacer/Plate