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China NMPA legacy archive 国械注准20243131840

Self-stabilizing cervical interbody fusion device

自稳型颈椎椎间融合器
Tianjin Zhengtian Medical Instrument Co., Ltd.Class IIINMPAApproved September 19, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class III
Approval department
State Drug Administration
国家药品监督管理局
Registration information
Registration number
国械注准20243131840
Approval date
September 19, 2024
Expiry date
September 18, 2029
Registrant
Name
Tianjin Zhengtian Medical Instrument Co., Ltd.
天津正天医疗器械有限公司
Province/Region
Tianjin
天津
Address
No. 318, Jingyi Road, Tianjin Airport Economic Zone
天津空港经济区经一路318号
Production facility
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)
Intended use
English

The product is suitable for interbody fusion of anterior cervical spine (C2~C7).

中文

产品适用于颈椎前路(C2~C7)的椎间融合术。

Structure and composition
English

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.

中文

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。

Additional information
Remark
无。
Appendix
产品技术要求
About this record

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.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.