可调节人工椎体
- Device class
- Class III
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243132286
- Approval date
- November 21, 2024
- Expiry date
- November 20, 2029
- 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1 7-1号一层、三层，17-2号一层A区、二层
It is suitable for single-segment and multi-segment vertebral body replacement of the thoracic and lumbar spine (T1-L5), replacement of vertebral bodies removed or separated during complete and partial vertebral body resection due to compression, damage or instability of the vertebral body or spine caused by tumor or trauma (such as fracture).
适用于胸腰椎（T1-L5）单节段及多节段椎体置换，置换由于肿瘤或外伤（如骨折）所致的椎体或脊椎压缩、损坏或不稳定而进行的完全和部分椎体切除术中切除或分离的椎体。
该产品由可调节人工椎体、延长器和端盖组成,采用符合ISO 5832-3标准规定的Ti6Al4V钛合金材料制成.限位钉表面经阳极氧化处理或不着色其余部件不着色.含灭菌和非灭菌包装.采用辐照灭菌,无菌包装有效期5年.
该产品由可调节人工椎体、延长器和端盖组成，采用符合ISO 5832-3标准规定的Ti6Al4V钛合金材料制成。限位钉表面经阳极氧化处理或不着色其余部件不着色。含灭菌和非灭菌包装。采用辐照灭菌，无菌包装有效期5年。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for 可调节人工椎体 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20243132286 and owned by Double Medical Technology Inc.. The device was approved on November 21, 2024.
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.