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510(k) Data Aggregation

    K Number
    K983006
    Device Name
    OSTEO 5.0MM CANNULATED SCREW SYSTEM
    Manufacturer
    STRYKER OSTEONICS
    Date Cleared
    1998-11-23

    (87 days)

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

    STRYKER OSTEONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Osteo 5.0mm Cannulated Screw System is indicated for ligament fixation and long and small bone fracture fixation, which may include the following: - Fixation of intermediate-sized fragments in fractures such as: . - proximal and distal humerus fractures - fractures of the olecranon process - femoral fractures - tibial plateau and metaphyseal fractures of the proximal and distal tibia - medial and lateral malleolar and pilon fractures - os calcis, talar, and patellar fractures - - . Ligament fixation of the proximal humerus - . Fractures of the pelvis and acetabulum - . Arthrodesis of the tarsals
    Device Description
    The Osteo 5.0mm Cannulated Screw System consists of 5.0mm thread diameter self-tapping cannulated screws of varying lengths and one washer, the use of which is optional. The 5.0mm screw has a thread diameter of 5.0mm, a shaft diameter of 3.2mm, a head diameter of 6.0mm, and a cannulation diameter of 2.0mm. The washer for the 5.0 screws has an outer diameter of 8.0mm, an inner diameter of 4.5mm, and a thickness of 1.0mm. The surfaces of the screws and washers are anodized with a Type II coating. The screws and washers are provided both sterile and non-sterile.
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