Self-stabilizing cervical interbody fusion device
- Device class
- Class III
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243131840
- Approval date
- September 19, 2024
- Expiry date
- September 18, 2029
- Province/Region
- Tianjin
- Address
- No. 318, Jingyi Road, Tianjin Airport Economic Zone
- Production address
- 天津空港经济区经一路318号;天津空港经济区经一路296号1号厂房二层南侧、一层(除仓库及B区)
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。
- Remark
- 无。
- Appendix
- 产品技术要求
This static archive preserves historical registration fields and translations for Self-stabilizing cervical interbody fusion device, registration 国械注准20243131840. It does not establish current authorization or complete current product details.
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