LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

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
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE ORTHOPAEDIC IMPLANT COMPANY (OIC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    Ask a Question

    Page 1 of 1