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

    3.7MM/5.0MM DYNAMIC LOCKING SCREW

    K Number: K110592 · Decision Jul 25, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    9
    Review Days
    145

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    Basic Information

    Device Name
    3.7MM/5.0MM DYNAMIC LOCKING SCREW
    K Number
    K110592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes USA
    Date Received
    March 2, 2011
    Decision Date
    July 25, 2011
    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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    Other Clearances by Synthes USA

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    K120854 SYNTHES VA LCP ANKLE TRAUMA SYSTEM
    K120717 SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
    K120070 SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
    K120083 SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
    K110125 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
    K110354 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM