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

    TRANSFX MULTI PIN CLAMP

    K Number: K991723 · Decision Jul 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    56
    Applicant Total
    8
    Review Days
    63

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    Basic Information

    Device Name
    TRANSFX MULTI PIN CLAMP
    K Number
    K991723
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Immedica, Inc.
    Date Received
    May 20, 1999
    Decision Date
    July 22, 1999
    Product Code
    LXT
    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
    LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

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    Other Clearances by Immedica, Inc.

    K Number Device Name
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    K001228 EXTERNAL FIXATION ANCHOR PIN
    K001084 TRANS FX ADJUSTABLE PIN TO BAR CLAMP
    K990848 TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION
    K984357 TRANSFX EXTERNAL FIXATION SYSTEM