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510(k) Data Aggregation

    K Number
    K061955
    Device Name
    RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS
    Manufacturer
    CREATIVE MEDICAL DESIGNS, INC.
    Date Cleared
    2006-08-04

    (24 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    CREATIVE MEDICAL DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Rayhack Low Profile Locking Plate is a metallic surgical implant intended for long bone fixation utilized to assist healing but not intended to replace normal body structures. The plate and screws which attach to the bone are temporary internal fixation devices which align the bone surfaces in order to permit bone healing.
    Device Description
    The Rayhacks Low Profile Locking Plate and Instruments is an implant intended for fixation of long bones to assist healing. The implant is fabricated from stainless steel. It is fixated with two 2.7mm locking screws, four 3.5mm standard cortical screws and one 2.7 standard interfragmentary cortical screw. In addition to the plate and screws, there are instruments intended to assist with the procedure.
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