Double-action hip system
- Device class
- Class III
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243131600
- Approval date
- August 27, 2024
- Expiry date
- August 26, 2029
- Province/Region
- Tianjin
- Address
- No. 318, Jingyi Road, Tianjin Airport Economic Zone
- Production address
- 天津空港经济区经一路318号,天津空港经济区经一路296号1号厂房二层南侧
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。
- Appendix
- 产品技术要求
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