Industry

November 3, 2026 Medical Device Approval Certificate Delivery Information

2026-11-02

On November 3, 2026, the National Medical Products Administration released medical device approval certificate delivery information covering a total of 57 acceptance numbers. Among them, the additively manufactured interbody fusion cage from Hunan Huaxiang Medical Technology Co., Ltd. (acceptance number CQX2501905, registration certificate number National Device Registration 20233130022) was approved on October 29, 2026, and is the only device in this list whose product name explicitly indicates an additive manufacturing process. The product is named for additive manufacturing, its registration certificate number is National Device Registration 20233130022, the approval date is October 29, 2026, and the applicant Hunan Huaxiang Medical Technology Co., Ltd. has no agent. The same batch list also includes the approval of several other orthopedic implants, including the metal locking intramedullary nail from Jiangsu Qianrui Medical Device Co., Ltd. (National Device Registration 20223130239, November 2, 2026), the CS-type anterior spinal internal fixation device from Beijing Chunlizhengda Medical Instruments Co., Ltd. (National Device Registration 20173130584, October 29, 2026), and the cannulated bone screw from Yunnan Oubosi Medical Technology Co., Ltd. (National Device Registration 20233130158, November 2, 2026). The names of the above products all contain references to metal materials, but the news content does not disclose their forming processes or the powder grades used. In this delivery information, the facts directly related to metal additive manufacturing are the product name of the additively manufactured interbody fusion cage, its registration certificate number, and its approval date; the news does not mention any metal powder suppliers, powder grades, particle size specifications, or additive manufacturing equipment information, nor does it explain the material system or printing process parameters of the fusion cage.

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2026年11月03日医疗器械批准证明文件送达信息

2026年11月3日，国家药品监督管理局发布医疗器械批准证明文件送达信息，共涉及57项受理号。其中，湖南华翔医疗科技有限公司的增材制造椎间融合器（受理号CQX2501905，注册证编号国械注准20233130022）于2026年10月29日获批，是本次清单中唯一在产品名称中明确标注增材制造工艺的器械。该产品以增材制造命名，注册证编号为国械注准20233130022，批准日期为2026年10月29日，申请人湖南华翔医疗科技有限公司无代理人。同批清单中另有多项骨科植入物获批，包括江苏乾瑞医疗器械有限公司的金属带锁髓内钉（国械注准20223130239，2026年11月2日）、北京市春立正达医疗器械股份有限公司的CS型脊柱前路内固定器（国械注准20173130584，2026年10月29日）以及云南欧铂斯医疗科技有限公司的空心接骨螺钉（国械注准20233130158，2026年11月2日），上述产品名称均含金属材质指向，但新闻内容未披露其成形工艺或所用粉末牌号。本次送达信息中，与金属增材制造直接关联的事实为增材制造椎间融合器这一产品名称及其注册证编号、批准日期；新闻未提及任何金属粉末供应商、粉末牌号、粒径规格或增材制造设备信息，亦未说明该融合器的材料体系与打印工艺参数。

🧪 Related Material Grades

Metal powder grades mentioned in this article — specs, live prices & verified suppliers

316L Stainless Steel Powder

15-45 µm / 15-53 µm

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17-4PH Stainless Steel Powder

15-45 µm / 15-53 µm

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Ti-6Al-4V (Grade 5) Titanium Powder

15-45 µm / 15-53 µm / 45-105 µm

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AlSi10Mg Aluminum Alloy Powder

15-45 µm / 20-63 µm

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Inconel 718 Nickel Superalloy Powder

15-45 µm / 15-53 µm

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18Ni300 Maraging Steel Powder

15-53 µm

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2026-11-04

IperionX Expands Titanium Capacity and Funding in Dual-Driven Growth

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2026-11-04

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