FDA 510(k)

SGM股骨钉系统

K号: K230456 · 2023-06-30

申请人Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

决定日期2023-06-30

产品代码HSB

咨询委员会OR 请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整： --- 产品名称：[产品名称] 公司名称：[公司名称] 根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。产品注册号：[注册号] PMA编号：[PMA编号] 临床试验编号（NCT）：[NCT编号] PubMed ID（PMID）：[PMID编号] 更多信息请访问以下链接： [URL] --- 请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。

决定实质等同

器械摘要

SGM Femoral Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K230456. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SGM Femoral Nail System?

SGM Femoral Nail System is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. The 510(k) number is K230456.

When did SGM Femoral Nail System receive FDA 510(k) clearance?

SGM Femoral Nail System received FDA 510(k) clearance on 2023-06-30, under 510(k) number K230456.

Who is the listed applicant for SGM Femoral Nail System?

The FDA 510(k) record lists Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SGM Femoral Nail System?

The FDA product code for SGM Femoral Nail System is HSB.

列明Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K232394内部锁定板和螺钉固定系统 K223776PEEK脊柱灌注笼 K222031脊柱内固定系统

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