聚醚醚酮敲入式免打结锚钉 - NMPA Registration 国械注准20253130145
Access comprehensive regulatory information for 聚醚醚酮敲入式免打结锚钉 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20253130145 and owned by Beijing Chunlizhengda Medical Instruments Co., Ltd.. The device was approved on January 20, 2025.
This page provides complete registration details including registrant information, province location (Beijing), 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.
本产品适用于足、踝、膝、手、腕、肘、肩和髋部的骨与软组织的连接固定。
该产品由植入物和辅助工具组成。聚醚醚酮敲入式免打结锚钉按照钉头形式的 不同分为PL、PM、PN和PQ四种型号 。植入物部分为PEEK锚钉, 由钉头和钉体组成 , 钉头和钉体为符合 YY/T0660的Optima LT3级聚醚醚酮（ PEEK）；辅助工具部 分为插入器、穿线器和固定件 ，插入器由内杆、外杆和手柄组成 。辅助工具中内 外杆材料为符合YY/T0294. 1的M号不锈钢 。产品经环氧乙烷灭菌 ，无菌包装 ，灭菌 有效期5年。