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510(k) Data Aggregation

    K Number
    K963937
    Device Name
    NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW
    Date Cleared
    1997-01-22

    (113 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTHWEST PRECISION TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Not Found
    Device Description
    The Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screw will be offered in two versions of an identical configuration. Both versions are identical with the exception of the overall thread length . One will be 16 mm and the second will be 32 mm in length. The length is measured from the distal tip up the shank. The screws will be fabricated from Titanium alloy Ti-6Al-4V, which complies with ASTM F-136. The device is of a single thread profile with a nominal major diameter of Ø6.5 mm (.256 in.) and a nominal shank, or minor diameter, of 4.82 mm (.190 in.). The lengths offered at this time are 30 mm through 150 mm, in 5 mm increments. The overall length is measured from the underside of the head to the distal tip. The cannula, or inner diameter, is a nominal Ø3.26 mm (1285 in.) bore which will allow the use of a Ø2.5 mm Guide Pin ensuring safe and accurate placement of the screw. The "head" portion off the screw will embody an internal hexagon pocket to facilitate the insertion / extraction instrumentation. The distal tip embodies a self reaming / self tapping design. The self reaming feature incorporates three cutting teeth, while the self tapping is accomplished with three cutting flutes. Two cutting flutes will be located at the thread runout to the shank. They will be located at 180° to each other. These flutes are provided to ease extraction of the device. The self reaming and self tapping cannulated screws simplify the surgical procedure by allowing the surgeon to place the screw directly over the guide pin which is holding the reduced fracture in place.
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