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510(k) Data Aggregation

    K Number
    K141106
    Device Name
    FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM
    Manufacturer
    FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES
    Date Cleared
    2014-10-10

    (164 days)

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

    FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FUSIO Screw Fuze System is intended for large bone fixation, including sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
    Device Description
    The Frontier Devices FUSIO Screw Fuze System consists of titanium bone screws of 7mm, 9.5mm, and 11mm diameter of various lengths to accommodate patient anatomy. An optional serrated washer can be placed on the screw. The screws are made from titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard.
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    K Number
    K100205
    Device Name
    FRONTIER DEVICES NEURO SYSTEM
    Manufacturer
    FOLSOM METAL PRODUCTS, INC.
    Date Cleared
    2010-12-13

    (322 days)

    Product Code
    GWO, GXR, HBW
    Regulation Number
    882.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOLSOM METAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Frontier Devices Neuro System is intended for use in selective trauma of the cranial skeleton and cranial surgery.
    Device Description
    The Frontier Devices Neuro System consists of titanium bone plates and screws of various shapes and sizes. The plates are made from unalloyed titanium that conforms to the ASTM F67 standard. Plates are 0.4 and 0.6 mm thick and come in a variety of shapes and sizes that are designed for cranial closure applications. The shapes and corresponding sizes include: Straight plates 9-12mm long (1x1, 2x2, 5 and 7 holes), Box plates 10mm x 10mm to 16mm x 16mm (4 hole), X-plate 8mm x 8mm (4 hole), Y-plate 16mm long (6 and 8 holes), Double Y-plate 18mm to 21mm long (6 and 8 hole), Strut plate 24 and 35mm long (6 and 8 hole). The burr hole covers are are made from unalloyed titanium that conforms to the ASTM F67 standard. They are 0.4 and 0.6 mm thick and are circular in shape with equi-spaced drill holes around the circumference. The burr hole covers have two basic shapes. The burr hole cover for shunt has a segment of the circular burr hole cover missing which is where a shunt device is placed. The other burr hole cover is a complete circle. The corresponding sizes include: Burr hole covers 12mm to 24mm diameter, Burr hole covers for shunt 12mm to 24mm diameter. The mesh is made from unalloyed titanium that conforms to ASTM F67 standard. They are 0.4 and 0.6mm thick and rectangular in shape, 90mm x 120mm. The screws are self-drilling screws that do not require a pre-drilled pilot hole and are made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard. Screws are 1.5 to 1.8 mm in diameter and range in length from 3 to 6 mm.
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