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

    LATERAL FLARE INTERNAL COLLAR (LFIC)

    K Number: K971900 · Decision Dec 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    80
    Applicant Total
    1
    Review Days
    209

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    Basic Information

    Device Name
    LATERAL FLARE INTERNAL COLLAR (LFIC)
    K Number
    K971900
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pro-Lfic, LLC
    Date Received
    May 23, 1997
    Decision Date
    December 18, 1997
    Product Code
    LWJ
    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
    LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

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