Pure Global

Metallic femoral head - Vietnam Registration 2300295ĐKLH/BYT-TB-CT

Access comprehensive regulatory information for Metallic femoral head 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 2300295ĐKLH/BYT-TB-CT and manufactured by Theo theo phụ lục.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including DePuy (Ireland), and 1 recent registrations in the same category. 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.

Free Database
Powered by Pure Global AI
300,000+ Devices
1 Competitors
1 Recent Registrations
2300295ĐKLH/BYT-TB-CT
Registration Details
Vietnam MOH Registration: 2300295ĐKLH/BYT-TB-CT
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Device Details

Metallic femoral head
VN: Chỏm xương đùi bằng kim loại
Risk Class TTBYT Loại C

Registration Details

2300295ĐKLH/BYT-TB-CT

17001883/ĐKLH-BYT-TB-CT

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Technical Details

The metal-on-metal ARTICUL/EZE femoral head is a component of the total hip arthroplasty system, designed to replace the natural joint surface of the hip. THE TOTAL HIP ARTHROPLASTY SYSTEM Total hip arthroplasty surgery is indicated to improve the mobility of the patient and reduce pain by replacing the damaged hip joint surface in patients who have been proven to have sufficient healthy bone to anchor and support the artificial joint components. INDICATIONS - THE TOTAL HIP ARTHROPLASTY SYSTEM Total hip arthroplasty surgery 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. Failure of previous hip surgery, including arthroplasty, intramedullary fixation, arthrodesis, hemiarthroplasty, surface resurfacing, or total hip arthroplasty. 5. Certain cases of joint stiffness. Total hip arthroplasty surgery may be considered in younger patients, if, in the opinion of the surgeon, the 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 the section WARNING AND PRECAUTIONS). This section includes severely disabled patients with multiple joint involvement, for whom the improvement in hip joint mobility may result in a significant improvement in quality of life. Modular femoral heads and stem components A modular metal femoral head or DePuy metal femoral head is used with the DePuy stem component. The socket is replaced with a two-piece UHMWPE socket component lined with metal, ceramic, or metal, or entirely with UHMWPE, and uses a UHMWPE load-bearing surface, or ceramic* with an internal diameter equal to the external diameter of the modular femoral head used.

Dates and Status

Apr 18, 2023

Companies Making Similar Products
Companies providing products similar to "Metallic femoral head"