Self-stabilizing interbody fusion cage
- Device class
- Class III
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253130017
- Approval date
- January 06, 2025
- Expiry date
- January 05, 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觅西二路10号、北京市通州区通州经济开发区南区鑫隅西三街13号
适用于腰椎和腰骶椎节段（L1-S1）的前路椎间融合。
产品由主体和锁定螺钉组成。主体是带有前路固定板的椎间融合器，内装有显影针。主体由符合YY/T 0660规定的聚醚醚酮（PEEK-OPTIMA LT1）材料制造，前路固定板和锁定螺钉由符合GB/T 13810规定的TC4材料制造，显影针由符合YY/T 0966规定的Ta1（纯钽）材料制造。前路固定板和锁定螺钉为无着色或着色阳极氧化处理。灭菌和非灭菌包装，灭菌包装采用辐射灭菌，有效期为5年。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Self-stabilizing interbody fusion cage 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20253130017 and owned by Beijing Chunlizhengda Medical Instruments Co., Ltd.. The device was approved on January 06, 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.