Intervertebral fusion device
- Device class
- Class III
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253130022
- Approval date
- January 06, 2025
- Expiry date
- January 05, 2030
- Name
- Double Medical Technology Inc.大博医疗科技股份有限公司
- Province/Region
- Fujian福建
- Address
- No. 18, Hongdong Road, Shanbian District, Haicang District, Xiamen厦门市海沧区山边洪东路18号
- Production address
- 厦门市海沧区山边洪东路18号主厂区，18-4号一层A区、二层、三层、四层A区；厦门市海沧区湖头路17-1号一层、三层，17-2号一层A区、二层
与同企业同系列脊柱内固定系统配合，适用于腰椎（L2-S1）的椎间融合术。
该产品由融合器主体和显影针组成，融合器主体由符合YY/T 0660标准要求的VESTAKEEP i4 PL聚醚醚酮（PEEK）材料制成，显影针由化学成分符合YY/T 0966标准要求的纯钽材料制成。非灭菌包装。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Intervertebral fusion device 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20253130022 and owned by Double Medical Technology Inc.. The device was approved on January 06, 2025.
This page provides complete registration details including registrant information, province location (Fujian), 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.