Artificial Knee Joint - Vietnam Registration 2403485ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Artificial Knee Joint 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 2403485ĐKLH/BYT-HTTB and manufactured by Groupe Lepine. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI - DỊCH VỤ VÀ SẢN XUẤT VIỆT TƯỜNG .

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Smith & Nephew, Inc.; Heraeus Medical Gmbh, Aesculap AG, and 5 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.

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2403485ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2403485ĐKLH/BYT-HTTB

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Device Details

Artificial Knee Joint

VN: Bộ khớp gối nhân tạo

Risk Class TTBYT Loại C

Registration Details

Analysis ID

2403485ĐKLH/BYT-HTTB

Submission ID

18005971/ĐKLH-BYT-TB-CT

Product Type

Theo theo phụ lục

Product Code

Theo phụ lục

Technical Details

Intended Use

Target: adult patients as determined by the physician.. The indications for knee arthroplasty are: Osteoarthritis, including primary or secondary osteoarthritis of the knee, Inflammation, including rheumatoid arthritis. Osteonecrosis (NEW WAVE) Failure with prior interventions such as bone grafting, joint reconstruction, arthroscopic surgery, knee arthroplasty, partial metal-on-metal hip resurfacing, with or without open femoral bone resection (NEW WAVE) Note: The long-stem implant may be indicated for cases of failed partial knee surgery or severe osteoporosis The geometry of NEW WAVE also provides solutions for the following specific indications: Weakness or deficiency of the anterior and posterior cruciate ligaments. The geometry of the components that make up the total knee KNEO requires the sacrifice of the anterior and posterior cruciate ligaments.