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

    MAXLOCK EXTREME SYSTEM

    K Number: K132591 · Decision Sep 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    25
    Review Days
    29

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    Basic Information

    Device Name
    MAXLOCK EXTREME SYSTEM
    K Number
    K132591
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthohelix Surgical Designs, Inc.
    Date Received
    August 19, 2013
    Decision Date
    September 17, 2013
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Orthohelix Surgical Designs, Inc.

    K Number Device Name
    K141004 INTRAOSSEOUS FIXATION SYSTEM
    K142148 ORTHOHELIX STAPLE SYSTEM
    K141301 MAXLOCK EXTREME ELBOW FRACTURE SYSTEM
    K132733 ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
    K130832 ORTHOHELIX STAPLE SYSTEM
    K131324 MAXTORQUE SCREW SYSTEM
    K123203 MAXLOCK EXTREME SYSTEM MODEL MXL
    K122005 MAXLOCK EXTREME SYSTEM
    K121437 MINI MAXLOCK EXTREME PLATING SYSTEM
    K120165 INTRAOSSEOUS FIXATION SYSTEM
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