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510(k) Data Aggregation

    K Number
    K081097
    Device Name
    ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
    Manufacturer
    ORTHOPEDIATRICS, LLC
    Date Cleared
    2008-06-03

    (47 days)

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

    ORTHOPEDIATRICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PediFlex (Flexible) Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.
    Device Description
    The nail is available in 2.0, 2.5, 3.0, 3.5, and 4.0 mm diameters, each 440 mm long, which can be cut to length intra-operatively. The PediFlex has a curved, tapered tip to facilitate insertion. This is a single use device intended for temporary implantation. It is intended to be removed once the bone has healed. Materials: The devices are manufactured from Ti-6Al-4V which meets ASTM F136, and ISO-5832 standards. Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.
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    K Number
    K073344
    Device Name
    ORTHOPEDIATRICS PLATING SYSTEM
    Manufacturer
    ORTHOPEDIATRICS, LLC
    Date Cleared
    2008-02-19

    (83 days)

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

    ORTHOPEDIATRICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrthoPediatrics Plating System is intended for use in the treatment of pelvic, small and long bone fractures.
    Device Description
    The OrthoPediatrics Pediatric Plating system is a system of bone plates and screws to provide the pediatric and general orthopedic surgeon with necessary devices to achieve optimal bone fixation when treating fractures, osteotomies, mal-unions, and mal-alignments. - Materials: The devices are manufactured from 316L stainless steel, which . meet ASTM F138 and F139, and ISO-5832 standards. - Eunction: The system functions to provide immediate stability and . temporary fixation during the natural healing process. The system includes cortical and cannulated screws, and specialty plates. The specialty plates will include three distinct shapes and each shape will be offered in multiple sizes to accommodate the individual requirements of the patient anatomy to aid the surgeon in achieving optimal fixation. The three specialty plates' shapes resemble the letters H and I, and the infinity symbol (similar to the number 8, lying on its side).
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