Hollow Intramedullary Nail - NMPA Registration 国械注准20233131509
Access comprehensive regulatory information for Hollow Intramedullary Nail 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20233131509 and owned by Henan Tuoren BEST MEDICAL Device Co., Ltd.. The device was approved on October 23, 2023.
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.
It can be used alone, suitable for internal fixation of limb fractures, and the product is limited to the femoral neck area.
可单独使用，适用于四肢骨折内固定，产品限制用于股骨颈部位。
The hollow bone screw is composed of standard hollow bone screws, headless fusion hollow bone screws, headless standard hollow bone screws, and spacers (optional). The hollow bone screws are made of TC4 ELI titanium alloy material in accordance with GB/T 13810, and the optional spacer for standard hollow bone screws is made of TA3G pure titanium material in accordance with GB/T 13810. The surface of the product is anodized with color, black and gray anodized or unanodized. Non-sterile supply.
空心接骨螺钉由标准型空心接骨螺钉、无头融合空心接骨螺钉、无头标准空心接骨螺钉、垫片（选配）组成。空心接骨螺钉由符合GB/T 13810规定的TC4 ELI钛合金材料制造；标准型空心接骨螺钉可选配的垫片由符合GB/T 13810规定的TA3G纯钛材料制造。产品表面经着色阳极氧化、黑灰色阳极氧化或者未经阳极氧化处理。非无菌提供。