Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K150561
    Device Name
    NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System
    Manufacturer
    Narang Medical Limited
    Date Cleared
    2015-11-25

    (264 days)

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

    Narang Medical Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NET Brand Small Fragment and Large Fragment Osteosynthesis System is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, distal femur, proximal tibial pilon, fibula, pelvis and acetabulum fractures; periprosthetic fractures; The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine. NET Brand DHS/DCS plating system may be used for fixation of the fractures of proximal femur such as femoral neck, trochanteric, pertrochanteric or intertrochanteric zones.
    Device Description
    NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System consists of plates and screws in a variety of designs and sizes and made from Ti-6Al-4V alloy or stainless steel. Plates are provided in straight designs and in various geometric configurations that are commonly used in trauma and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screws designs. Screws are provided in, 3.5mm Cortex Self-tapping, 4.5 mm Cortex self-tapping and 2.7mm self-tapping cortex locking, 3.5mm selftapping Cortex Locking, 5.0 mm cortex Locking thread designs in various lengths. This system is not indicated for use in spine. NET Brand of DHS/DCS Plating System made from Ti-6Al-4V alloy or stainless steel and consist of DHS/DCS Plates, lag Screw, compression screw, and 4.5 Cortex screw Self Tapping, The DHS plates are available with barrel length 25mm (short barrel) and 38mm (Standard barrel) and barrel angels varies in 130° to 150°. The DCS plate is having angle of 95° The DHS/DCS Screw is available in total length from 50 to 145 mm, thread length 22mm, shaft diameter 7 mm and outer diameter of 12.5. The thread of DHS/DCS Screw has a buttress type. The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 36mm and outer diameter 4.0 mm.
    Ask a Question

    Page 1 of 1