Patient-matched joint filler blocks - NMPA Registration 国械注准20243131544
Access comprehensive regulatory information for Patient-matched joint filler blocks 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20243131544 and owned by Tianjin Zhengtian Medical Instrument Co., Ltd.. The device was approved on August 22, 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.
The product is bio-fixed with bone or screw-and-bio-fixation, and with joint replacement prosthesis by bone cement, and is suitable for filling periarticular bone defects during revision and replacement of hip and knee joints.
该产品与骨通过生物固定或螺钉和生物固定、与关节置换假体通过骨水泥固定，适用于髋关节和膝关节的翻修置换术中关节周围骨缺损的填充。
The patient-matched joint filling block is made of Ti6Al4V titanium alloy powder material in accordance with ISO 5832-3 by additive manufacturing technology. The product is delivered in a non-sterile state.
患者匹配关节填充块由符合ISO 5832-3规定的Ti6Al4V钛合金粉末材料经增材制造技术制成。产品以非灭菌状态交付。