BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)

    K Number: K031401 · Decision Aug 6, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    249
    Registration Numbers
    249
    Same Product Code
    403
    Applicant Total
    9
    Review Days
    93

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    Basic Information

    Device Name
    FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)
    K Number
    K031401
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Disco-O-Tech Medical Technologies, Ltd.
    Date Received
    May 5, 2003
    Decision Date
    August 6, 2003
    Product Code
    KTT
    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
    KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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    Other Clearances by Disco-O-Tech Medical Technologies, Ltd.

    K Number Device Name
    K032588 MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)
    K023437 FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL
    K021324 FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)
    K012967 MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM
    K003212 FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
    K003215 MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
    K002783 FIXION INTERLOCKING NAIL (FIXION IL NAIL)
    K990717 FIXION INTRAMEDULLARY NAILING SYSTEM