FDA 510(k)

富乐金属锁定髓内钉系统

K号: K253155 · 2026-06-17

申请人Beijing Fule Science & Technology Development Co., Ltd.

决定日期2026-06-17

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

Fule Metallic Lockable Intramedullary Nail Systems is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Fule Science & Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K253155. 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 Fule Metallic Lockable Intramedullary Nail Systems?

Fule Metallic Lockable Intramedullary Nail Systems is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Beijing Fule Science & Technology Development Co., Ltd.. The 510(k) number is K253155.

When did Fule Metallic Lockable Intramedullary Nail Systems receive FDA 510(k) clearance?

Fule Metallic Lockable Intramedullary Nail Systems received FDA 510(k) clearance on 2026-06-17, under 510(k) number K253155.

Who is the listed applicant for Fule Metallic Lockable Intramedullary Nail Systems?

FDA 510(k)记录将北京富乐科技有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Fule Metallic Lockable Intramedullary Nail Systems?

The FDA product code for Fule Metallic Lockable Intramedullary Nail Systems is HSB.

列明Beijing Fule Science & Technology Development 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。

K260203富勒椎体成形术球囊导管 K253151富乐椎间融合笼系统 K252730富乐脊柱固定系统

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