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

    EPIPHYSIS SCREW

    K Number: K043410 · Decision Feb 24, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    13
    Review Days
    76

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    Basic Information

    Device Name
    EPIPHYSIS SCREW
    K Number
    K043410
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I.T.S. Implantat-Technologie-Systeme GmbH
    Date Received
    December 10, 2004
    Decision Date
    February 24, 2005
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

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