髁限制型膝关节假体 - NMPA Registration 国械注准20253130048
Access comprehensive regulatory information for 髁限制型膝关节假体 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20253130048 and owned by Tianjin Zhengtian Medical Instrument Co., Ltd.. The device was approved on January 06, 2025.
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.
与骨水泥配合使用，适用于膝关节翻修置换。
该产品由股骨髁假体、半月板衬垫、胫骨平台假体、延长杆、转接头、垫块、胫骨袖套、螺钉、固定钉、盖帽组成。股骨髁假体由主体和螺钉组成，分别由符合YY 0117.3标准的铸造钴铬钼合金、符合GB/T 13810标准的锻造Ti6Al4V合金制成。半月板衬垫由主体和固定钉组成，分别由符合ISO 5834-2标准的2型超高分子量聚乙烯、符合GB/T 13810标准的锻造Ti6Al4V合金制成。胫骨平台假体由主体、螺钉、盖帽组成，分别由符合YY 0117.3标准的铸造钴铬钼合金、符合GB/T 13810标准的锻造Ti6Al4V合金、符合ISO 5834-2标准的2型超高分子量聚乙烯制成。延长杆、胫骨袖套、螺钉和固定钉由符合GB/T 13810标准的锻造Ti6Al4V合金制成。转接头由主体和螺钉组成，由符合GB/T 13810标准的锻造Ti6Al4V合金制成。垫块由主体和螺钉组成，由符合GB/T 13810标准的锻造Ti6Al4V合金制成。盖帽由符合ISO 5834-2标准的2型超高分子量聚乙烯制成。产品以灭菌状态交付，采用伽马射线辐照灭菌，灭菌有效期为5年。