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510(k) Data Aggregation

    K Number
    K233150
    Device Name
    NET BRAND Osteosynthesis Nailing System
    Manufacturer
    Narang Medical LTD.
    Date Cleared
    2024-02-20

    (146 days)

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

    Narang Medical LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NET BRAND Osteosynthesis Nailing System are provided non-sterile. Tibial Nails are indicated for stabilization of fractures of proximal and distal tibial shaft, open and closed tibial shaft fractures, certain pre and postisthmic fractures, non-unions and malunions. Femoral Nails are indicated for stabilization of femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. The Elastic Nails are indicated for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or the flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in paediatric or small statured patients, the flexibility of the elastic intramedullary nailing allows it to be inserted at a point which avoids disruption of the bone growth plate. All Implants are for single use only.
    Device Description
    NET BRAND Osteosynthesis Nailing System consists of various shape and sizes of Nails and Screws, Locking Bolts. The NET BRAND Osteosynthesis Nailing System are fabricated from Stainless Steel And Titanium. The system contains several models based on the size of the device and application site such as fixation/reconstruction of Tibia and Femoral bones appropriate for the device. The Nail implants are available in many diameters and lengths. These all are mainly divided into - Tibia Nail - Femoral Nail - Elastic Nail - Corresponding Screws and Locking Bolts for Fixations of These Nails. These implants are supplied non-sterile, the products have to be sterilized prior to use.
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