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510(k) Data Aggregation

    K Number
    K123832
    Device Name
    OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME
    Manufacturer
    THE ORTHOPAEDIC IMPLANT COMPANY (OIC)
    Date Cleared
    2013-03-20

    (97 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE ORTHOPAEDIC IMPLANT COMPANY (OIC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    a: Distal Radius Plates are indicated for the fixation of Intra- and extra-articular fractures and ostectomies of the distal radius.
    b. Clavice plates are indicated for the fixation of fractures, mal-unions, non-unions and ostectomies of the clavicie.
    c. Proximal Humerus plates are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus, particularly in the osteopenic bone.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) premarket notification letter from the FDA regarding orthopedic plating systems. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details related to proving a device meets acceptance criteria. The document only confirms the substantial equivalence of the OIC Distal Radius Plating System, OIC Proximal Humerus Plating System, and OIC Clavicle Plating System to legally marketed predicate devices.

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