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

    LUNDEEN SUBTALAR PEG IMPLANT

    K Number: K922292 · Decision Oct 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    8
    Review Days
    161

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    Basic Information

    Device Name
    LUNDEEN SUBTALAR PEG IMPLANT
    K Number
    K922292
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sgarlato Laboratories, Inc.
    Date Received
    May 15, 1992
    Decision Date
    October 23, 1992
    Product Code
    MJW
    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
    MJW Prosthesis, Subtalar, Plug, Polymer

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