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

    GREAT TOE IMPLANT SYSTEM

    K Number: K014164 · Decision Mar 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    1
    Review Days
    83

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    Basic Information

    Device Name
    GREAT TOE IMPLANT SYSTEM
    K Number
    K014164
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3730
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Harmos Orthopaedics, Inc.
    Date Received
    December 19, 2001
    Decision Date
    March 12, 2002
    Product Code
    KWD
    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
    KWD Prosthesis, Toe, Hemi-, Phalangeal

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