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510(k) Data Aggregation

    K Number
    K091812
    Device Name
    FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS
    Manufacturer
    FRONTIER DEVICES, INC.
    Date Cleared
    2010-05-07

    (323 days)

    Product Code
    JEY, DZL
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRONTIER DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Frontier Devices Maxillofacial System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. Frontier Devices Orthognathic System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The Frontier Devices Mandible Reconstructive System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. Frontier Devices Mesh System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
    Device Description
    Frontier Devices Maxillofacial System: implantable bone screws and plates for oral and maxillofacial procedures including fractures, orthognathic, reconstructive procedures and revisions procedures when other treatments of devices have failed. Plates are made from medical grade unalloyed titanium (commercially pure Titanium grade 4, ASTM F-67). Screws are made from alloyed titanium (Titanium 6Al 4V, ASTM F-136). Frontier Devices Orthognathic System: titanium bone plates and screws of various shapes and sizes. Plates are made from unalloyed titanium that conforms to the ASTM F67 standard. Screws are self-tapping screws made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard. Frontier Devices Mandible Reconstruction System: titanium bone plates and screws of various shapes and sizes intended for use for maxillofacial, orbital reconstruction and specialized orthognathic surgery. Plates are made from unalloyed titanium that conforms to the ASTM F67 standard. Screws are self-tapping screws made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard. Frontier Devices Mesh System: titanium meshes and screws of various shapes and sizes. Meshes are made from unalloyed titanium that conforms to the ASTM F67 standard. Screws are self-drilling screws made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard.
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