BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SGARLATO LESSER TOE IMPLANT

    K Number: K884739 · Decision May 18, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    20
    Applicant Total
    8
    Review Days
    185

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    Basic Information

    Device Name
    SGARLATO LESSER TOE IMPLANT
    K Number
    K884739
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3720
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Sgarlato Laboratories, Inc.
    Date Received
    November 14, 1988
    Decision Date
    May 18, 1989
    Product Code
    KWH
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KWH Prosthesis, Toe, Constrained, Polymer

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