BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

    PMA: P150017 · Supplement: S007 · Decision Aug 28, 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 reusable instrumentation
    PMA Number
    P150017
    Supplement Number
    S007
    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
    August 28, 2018
    Date Received
    November 15, 2017
    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 Arcamed LLC, 5101 Decatur Blvd Ste A, Indianapolis, Indiana to manufacture the instruments for Cartiva Synthetic Cartilage 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