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China NMPA legacy archive 国械注准20243131600

Double-action hip system

双动髋关节系统
Tianjin Zhengtian Medical Instrument Co., Ltd.Class IIINMPAApproved August 27, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class III
Approval department
State Drug Administration
国家药品监督管理局
Registration information
Registration number
国械注准20243131600
Approval date
August 27, 2024
Expiry date
August 26, 2029
Registrant
Name
Tianjin Zhengtian Medical Instrument Co., Ltd.
天津正天医疗器械有限公司
Province/Region
Tianjin
天津
Address
No. 318, Jingyi Road, Tianjin Airport Economic Zone
天津空港经济区经一路318号
Production facility
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
Intended use
English

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.

中文

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。

Structure and composition
English

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.

中文

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。

Additional information
Appendix
产品技术要求
About this record

This static archive preserves historical registration fields and translations for Double-action hip system, registration 国械注准20243131600. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.