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Metallic anchor without cement - Vietnam Registration 2400433ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Metallic anchor without cement 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 2400433ĐKLH/BYT-HTTB and manufactured by DePuy Orthopaedics, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH JOHNSON & JOHNSON (VIỆT NAM).

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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2400433ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2400433ĐKLH/BYT-HTTB
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Device Details

Metallic anchor without cement
VN: Ổ cối kim loại không xi măng
Risk Class TTBYT Loại C

Registration Details

2400433ĐKLH/BYT-HTTB

17003310/ĐKLH-BYT-TB-CT

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

DePuy Orthopaedics, Inc.

Technical Details

This product is a component of the total hip arthroplasty system and the self-centering hip arthroplasty system, which are indicated for use without bone cement in total hip and partial hip replacement surgery. INDICATIONS FOR USE Total hip arthroplasty is indicated to improve the mobility of the patient and reduce pain by replacing the damaged surface of the hip joint in patients who have been proven to have sufficient healthy bone to anchor and support the prosthesis. INDICATIONS Total hip arthroplasty is indicated in the following conditions: 1. Severe pain and/or hip joint disability due to chronic arthritis, arthritis after trauma, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute fracture of the femoral head or neck due to trauma. 4. Failed previous hip surgery, including arthroplasty revision, intramedullary fixation, arthroplasty stabilization, surface replacement arthroplasty, or total hip arthroplasty. 5. Certain cases of joint stiffness. INDICATIONS The self-centering total hip arthroplasty system and the partial hip arthroplasty system are indicated for use in partial hip arthroplasty surgery when there is evidence of a competent natural acetabulum and sufficient femoral bone to anchor and support the femoral stem. INDICATIONS Partial hip arthroplasty is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be treated effectively with intramedullary fixation. 2. Dislocation of the hip joint that cannot be treated effectively with intramedullary fixation. 3. Avascular necrosis of the femoral head. 4. Nonunions of the femoral neck. 5. Certain cases of high femoral neck fractures in the elderly. 6. Osteoarthritis of the hip joint that affects only the femoral head and does not require replacement of the acetabulum. 7. Conditions that affect only the femoral head/neck and/or the greater trochanter of the femur and can be effectively treated with partial hip arthroplasty. Total hip or partial hip arthroplasty may be considered in younger patients, if, in the opinion of the surgeon, a clear indication for total hip arthroplasty outweighs the risks associated with the patient's age and if the requirements for range of motion and load-bearing of the hip joint can be met (see section WARNINGS AND PRECAUTIONS). This section includes severely disabled patients with multiple joint involvement, for whom increased hip mobility may result in a significant improvement in quality of life.

Dates and Status

Apr 10, 2024