Internal fixation system of the posterior nail rod of the thoracolumbar spine
- Device class
- Class III
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243130022
- Approval date
- January 04, 2024
- Expiry date
- January 03, 2029
- Name
- Henan Tuoren BEST MEDICAL Device Co., Ltd.河南驼人贝斯特医疗器械有限公司
- Province/Region
- Henan河南
- Address
- Changyuan City Nanpu Street Office Weiqi Road Middle Road South长垣市南蒲街道办事处纬七路中段路南
- Production address
- 长垣市南蒲街道办事处纬七路中段路南
This product is suitable for posterior fixation of the spine, thoracic and lumbar spine.
该产品适用于脊柱胸腰椎后路内固定。
The product is composed of screws, fixing rods, hold-down nuts, self-breaking screw plugs, and transverse connectors, the screw assembly hold-down ring is made of TA3G pure titanium material in accordance with GB/T 13810 standard, and other components are made of TC4ELI titanium alloy material in accordance with GB/T 13810 standard. The surface of the product can be colored or anodized in black and grey. Non-sterile packaging.
该产品由螺钉、固定棒、压紧螺母、自断螺塞、横连器组成，螺钉组件压紧环采用符合GB/T 13810标准规定的TA3G纯钛材料制成，其他组件采用符合GB/T 13810标准规定的TC4ELI钛合金材料制成。产品表面可经着色或黑灰色阳极氧化处理。非灭菌包装。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Internal fixation system of the posterior nail rod of the thoracolumbar spine 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20243130022 and owned by Henan Tuoren BEST MEDICAL Device Co., Ltd.. The device was approved on January 04, 2024.
This page provides complete registration details including registrant information, province location (Henan), 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.