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

    Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

    PMA: P150017 · Supplement: S009 · Decision Jul 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
    Trade Name
    Cartiva SCI
    PMA Number
    P150017
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    PNW
    Generic Name
    Prosthesis, metatarsophalangeal joint cartilage replacement implant
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 2, 2018
    Date Received
    June 6, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Add an additional clean room for use in the manufacture of Cartiva SCI Implant.

    Classifications

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

    Product Code Device Name
    PNW Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant