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China NMPA legacy archive 国械注准20233131493

Internal fixation system of the posterior nail rod of the thoracolumbar spine

胸腰椎后路钉棒内固定系统
Henan Tuoren BEST MEDICAL Device Co., Ltd.Class IIINMPAApproved October 12, 2023
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20233131493
Approval date
October 12, 2023
Expiry date
October 11, 2028
Registrant
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 facility
Production address
长垣市南蒲街道办事处纬七路中段路南
Intended use
English

It is suitable for posterior fixation of the spine, thoracic and lumbar spine.

中文

适用于脊柱胸腰椎后路内固定。

Structure and composition
English

The product is composed of screws, fixing rods, hold-down nuts, self-breaking screw plugs, and cross-connectors, and is made of TC4ELI titanium alloy material that conforms to the GB/T 13810 standard. The surface of the product includes coloring oxidation, black-gray oxidation and no surface oxidation treatment. Non-sterile packaging.

中文

该产品由螺钉、固定棒、压紧螺母、自断螺塞、横连器组成,采用符合GB/T 13810标准规定的TC4ELI钛合金材料制成。产品表面包括着色氧化、黑灰色氧化和无表面氧化处理。非灭菌包装。

Additional information
Appendix
产品技术要求
About this record

This static archive preserves historical registration fields and translations for Internal fixation system of the posterior nail rod of the thoracolumbar spine, registration 国械注准20233131493. 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.