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510(k) Data Aggregation

    K Number
    K081608
    Device Name
    PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)
    Manufacturer
    TOBY ORTHOPAEDICS, LLC
    Date Cleared
    2008-12-19

    (193 days)

    Product Code
    HRSHWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOBY ORTHOPAEDICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Proximal Humerus Scaffold Fixation System (PHSFS) is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.
    Device Description
    The Proximal Humerus Scaffold Fixation System (PHSFS) is intended for the repair of proximal humeral fractures. The system consists of a titanium plate, posts, cross-pegs, cortical screws, 1.5 mm K-Wires, manual surgical instruments, alignment fixture and a custom sterilization container.
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