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510(k) Data Aggregation

    K Number
    K230867
    Device Name
    Bone Bolt System
    Manufacturer
    University of Utah, Department of Orthopaedics
    Date Cleared
    2023-06-26

    (89 days)

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

    University of Utah, Department of Orthopaedics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3.5mm, 4.0mm and 4.5mm Bone Bolt System is indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bone fragments, long bones, and long bone fragments of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, and fibula, and the bones of the hand and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by Bone Bolt fixation. The 5.0mm, 6.0mm and 7.0mm Bone Bolt System is indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments of humerus, radius, ulna, tibia, femur and fibula, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by Bone Bolt fixation.
    Device Description
    The Bone Bolt System consists of various sizes and lengths of bolts and nut-sleeves, which are implanted from opposing bone surfaces to provide stabilization of bones and bone fragments for the fixation of fractures, arthrodeses, and osteotomies. The bolts and nut-sleeves are cannulated for use with guidewires for precise placement in bone. The Bone Bolt System includes optional washers of various sizes.
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