Artificial Knee Joint
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Groupe Lepine·Registered Nov 14, 2024- Analysis ID
- 2403485ĐKLH/BYT-HTTB
- Submission ID
- 18005971/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Groupe Lepine
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Groupe Lepine
- Authorized Representative
- CÔNG TY TNHH THƯƠNG MẠI - DỊCH VỤ VÀ SẢN XUẤT VIỆT TƯỜNG
- 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.
- Registration Date
- Nov 14, 2024
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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.