Double-action hip system - NMPA Registration 国械注准20243131600
Access comprehensive regulatory information for Double-action hip system in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243131600 and owned by Tianjin Zhengtian Medical Instrument Co., Ltd.. The device was approved on August 27, 2024.
This page provides complete registration details including registrant information, province location (Tianjin), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
It is matched with the same system product of the company and is used as a cementless hip prosthesis, which is suitable for hip replacement.
与该企业同一系统产品匹配，作为非骨水泥型髋关节假体使用，适用于髋关节置换。
The double-acting hip joint system consists of a ball joint, a double-acting metal lining, a double-acting polyethylene lining, a plugging nail, and an acetabular screw. The ball head is made of cast cobalt-chromium-molybdenum alloy in accordance with YY 0117.3. The double-acting metal lining is made of a cast cobalt-chromium-molybdenum alloy in accordance with YY 0117.3. The double-acting polyethylene lining is made of high-cross-linked ultra-high molecular weight polyethylene material containing vitamin E in accordance with YY/T 0811. Both acetabular screws and plugging nails are made of forged Ti6Al4V titanium alloy in accordance with GB/T 13810 standard. The product is delivered in a sterilized condition with a sterilization expiration date of 5 years.
双动髋关节系统由球头、双动金属内衬、双动聚乙烯内衬、封堵钉、髋臼螺钉组成。球头由符合YY 0117.3的铸造钴铬钼合金制成。双动金属内衬由符合YY 0117.3的铸造钴铬钼合金制成。双动聚乙烯内衬由符合 YY/T 0811的含维生素E高交联超高分子量聚乙烯材料制成。髋臼螺钉和封堵钉均由符合 GB/T 13810标准的锻造Ti6Al4V 钛合金制成。产品以灭菌状态交付，灭菌有效期为5年。