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Internal fixation system of the posterior nail rod of the thoracolumbar spine - NMPA Registration 国械注准20233131493

Access comprehensive regulatory information for Internal fixation system of the posterior nail rod of the thoracolumbar spine 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20233131493 and owned by Henan Tuoren BEST MEDICAL Device Co., Ltd.. The device was approved on October 12, 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.

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Class III
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
NMPA Registration Number: 国械注准20233131493
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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。

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
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