Shoulder joint prosthesis - NMPA Registration 国械注准20243131632
Access comprehensive regulatory information for Shoulder joint prosthesis 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20243131632 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.
This product is an upright shoulder joint prosthesis, which is used in conjunction with bone cement and is suitable for shoulder replacement.
该产品为正置型肩关节假体，与骨水泥配合使用，适用于肩关节置换。
The shoulder prosthesis consists of the humeral stem, glenoid, and humeral head. The humeral shank is made of forged Ti6Al4V titanium alloy according to ISO 5832-3 and has a coating on the proximal surface made of pure titanium that meets the requirements of ASTM F1580. The glenoid is made of type II ultra-high molecular weight polyethylene according to ISO 5834-2 with developing filaments made of forged Ti6Al4V titanium alloy according to ISO 5832-3. The humeral head is made of a wrought cobalt-chromium-molybdenum alloy material that meets the requirements of ISO 5832-12. The product is sterilized by gamma irradiation, and the sterilization validity period is 5 years.
肩关节假体由肱骨柄、关节盂、肱骨头组成。肱骨柄由符合ISO 5832-3标准规定的锻造Ti6Al4V钛合金材料制成，近端表面带有符合ASTM F1580标准要求的纯钛材料制成的涂层。关节盂由符合ISO 5834-2标准规定的II型超高分子量聚乙烯材料制成，带有符合ISO 5832-3标准规定的锻造Ti6Al4V钛合金材料制成的显影丝。肱骨头由符合ISO 5832-12标准规定的锻造钴铬钼合金材料制成。产品采用伽玛射线辐照灭菌，灭菌有效期5年。