Self-stabilizing cervical interbody fusion device - NMPA Registration 国械注准20243131840
Access comprehensive regulatory information for Self-stabilizing cervical interbody 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20243131840 and owned by Tianjin Zhengtian Medical Instrument Co., Ltd.. The device was approved on September 19, 2024.
This page provides complete registration details including registrant information, province location (Tianjin), 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.
The product is suitable for interbody fusion of anterior cervical spine (C2~C7).
产品适用于颈椎前路（C2～C7）的椎间融合术。
The self-stabilizing cervical interbody fusion device consists of a combined fusion device and fixing screws. The combined fusion device consists of a combination plate and a fusion device or a combination plate, a pressing nail and a fusion device. The fuser is made of polyetheretherketone (PEEK OPTIMA LT1) material in accordance with YY/T 0660-2008, and the developing filament made of pure tantalum (R05200) material in accordance with YY/T 0966-2014 is embedded inside the fuser. The combination plate, pressure nails and fixing screws are made of TC4 titanium alloy material in accordance with GB/T 13810-2017. The surfaces of composite plates, pressure nails and set screws are anodized with tint or metal. The product is delivered in both sterile and non-sterile condition, the sterile product is irradiated and has a shelf life of 5 years.
自稳型颈椎椎间融合器由组合式融合器和固定螺钉组成。组合式融合器由组合板和融合器组成或组合板、压钉和融合器组成。融合器由符合YY/T 0660-2008的聚醚醚酮（PEEK OPTIMA LT1）材料制成，融合器内部嵌有符合YY/T 0966-2014的纯钽（R05200）材料制成的显影丝。组合板、压钉和固定螺钉由符合GB/T 13810-2017的TC4钛合金材料制成。组合板、压钉和固定螺钉的表面经着色阳极氧化处理或保持金属本色。产品以无菌和非无菌两种状态交付，无菌产品经辐照灭菌，有效期为5年。