BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ARTHROPLASTY MALLET

    K Number: K872209 · Decision Jun 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    206
    Registration Numbers
    206
    Same Product Code
    2
    Applicant Total
    18
    Review Days
    14

    Basic Information

    Device Name
    ARTHROPLASTY MALLET
    K Number
    K872209
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    NEW ENGLAND SURGICAL INSTRUMENT CORP.
    Date Received
    June 9, 1987
    Decision Date
    June 23, 1987
    Product Code
    HXL
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HXL Mallet

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