聚醚醚酮敲入式免打结锚钉
- Device class
- Class III
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253130145
- Approval date
- January 20, 2025
- Expiry date
- January 19, 2030
- Name
- Beijing Chunlizhengda Medical Instruments Co., Ltd.北京市春立正达医疗器械股份有限公司
- Province/Region
- Beijing北京
- Address
- No. 10, Xinmi West 2nd Road, South District, Tongzhou Economic Development Zone, Tongzhou District, Beijing北京市通州区通州经济开发区南区鑫觅西二路10号
- Production address
- 北京市通州区通州经济开发区南区鑫隅三街13号，北京市通州区通州经济开发区南区鑫觅西二路10号
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。
- Appendix
- 产品技术要求
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.