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Bone grafting implant used in orthopedic trauma surgery - Vietnam Registration 2403620ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Bone grafting implant used in orthopedic trauma surgery in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403620ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH HÀ NỘI IEC.

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2403620ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2403620ĐKLH/BYT-HTTB
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Device Details

Bone grafting implant used in orthopedic trauma surgery
VN: Bộ cấy ghép dùng trong phẫu thuật chấn thương chỉnh hình
Risk Class TTBYT Loại C

Registration Details

2403620ĐKLH/BYT-HTTB

19009318/ĐKLH-BYT-TB-CT

Theo theo phụ lục

Theo phụ lục

Company Information

Technical Details

-Used in orthopedic trauma surgery and bone fusion surgery. Specifically: -Indications for Bone Screws: including the bone screw for the femoral head, the bone screw for the acetabulum (bone screw for porous bone/porous bone screw): +The bone screw can only be used or combined with the systems or implants of Implantcast GmbH. Before combining the bone screw with implants of the same manufacturer, it is necessary to carefully consider the indications of the relevant system. +The bone screw is used in primary total hip replacement and revision hip replacement. The bone screw plays the role of primary fixation for the implant and also stabilizes the load of the implant on the bone. In addition, they have the effect of temporary fixation as well as permanent fixation of the implant into the bone. -Indications for the Femoral Head Screw: +The surgical technique of large femoral head resection is applied in: primary total hip replacement; revision total hip replacement; +The fixation of fractures at the upper end of the femur in cases of: comminuted fracture; fracture under the femoral head; fracture of the femoral head; large comminuted fracture; -Indications for the Titanium Plate: It is indicated for the fixation of the broken bone in the area of the bone fusion. The 8mm titanium plate is used to treat fractures of large cancellous bones and is produced in two versions (Smooth surface and Rough surface in contact with bone). During surgery, the surgeon will adjust and clamp it with a special tool to stretch the length of the plate, thereby encompassing the entire bone area, with the aim of applying sufficient force to the bone. The plate is also used as a prophylactic measure in cases of revision arthroplasty to prevent the risk of delayed union. -Indications for the Cement Stopper/Cement Stopper: The cement stopper/cement stopper is designed to be inserted into the bone marrow canal of the bone (e.g., femur, tibia, or humerus) in orthopedic surgery to prevent the progression of cement into the bone marrow, thus facilitating the cement pressure in the process of implantation. The cement stopper is combined with a radiographic orientation wire and is not indicated for spinal surgery. -Some precautions: +Decisions to undergo joint replacement or combined bone surgery must be based on careful evaluation. Indications for these procedures should only be performed when all other surgical or non-surgical alternatives are less promising. +The risk of complications after surgery can be reduced by carefully evaluating the individual patient's anatomical and loading conditions, the condition of the soft tissues, and the bone for the implant. +Implant surgery is usually indicated only in patients with fully developed skeletons. Preoperative tests and examinations are required. The tests and examinations are based on the patient's medical history. +The orthopedic surgeon will decide which implant to use for each patient. This decision is based on various factors such as the patient's age and weight, the quality of the bone, the shape of the bone, and the deformity of the joint.

Dates and Status

Nov 19, 2024