BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

    PMA: P150017 · Supplement: S013 · Decision Feb 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
    Trade Name
    Cartiva Synthetic Cartilage Implant (Cartiva SCI)
    PMA Number
    P150017
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    PNW
    Generic Name
    Prosthesis, metatarsophalangeal joint cartilage replacement implant
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 9, 2020
    Date Received
    August 5, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at Steris (Synergy Health AST, LLC), 7225 North Noah Drive, Saxonburg, Pennsylvania, 16056-9704 for device sterilization.

    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