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510(k) Data Aggregation

    K Number
    K151692
    Device Name
    BioArchitects Patient Specific Cranial/Craniofacial Plate
    Manufacturer
    BioArchitects USA, LLC
    Date Cleared
    2015-11-20

    (150 days)

    Product Code
    GXN
    Regulation Number
    882.5330
    Why did this record match?
    Applicant Name (Manufacturer) :

    BioArchitects USA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bio Architects Patient Specific Cranial/Craniofacial Plate implant device is intended to replace bony voids in the cranial and/or craniofacial skeleton (e.g., frontal bone, occipital bone, nasal bone, parietal bone, supraorbital process, lacrimal bone, zygomatic bone, ethmoid process, vomer). It is a patient specific device.
    Device Description
    The BioArchitects Patient Specific Cranial/Craniofacial Plate implant device is a single piece device constructed individually for each patient. It is intended to replace bony voids in the cranial and craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, nasal bone, parietal bone, supraorbital process, lacrimal bone, zygomatic bone, sphenoid bone, ethmoid process, vomer). It is a patient specific device. The implant is made of titanium alloy produced via Electron Beam Melting (EBM) additive manufacturing/3D printing, permitting high temperature fusion of the powdered raw material (Ti6Al4V ELI in accordance with ASTM F3001-14). The BioArchitects plate implants come in a variety of configurations that depend upon the geometry of the application. The surgeon approves the design of the cranial/craniofacial plate by comparing his/her dimension and configuration specifications to an engineering drawing prior to construction of the implant device.
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