FDA 510(k)

Tera Lumbar椎间融合系统（各种PN）

K号: K251335 · 2025-06-02

决定日期2025-06-02

产品代码MAX

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

Tera Lumbar Interbody Fusion System (Various PNs) is the device name listed in this FDA 510(k) record. The listed applicant is Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2025-06-02 under 510(k) number K251335. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tera Lumbar Interbody Fusion System (Various PNs)?

Tera Lumbar Interbody Fusion System (Various PNs) is a medical device that received FDA 510(k) clearance on 2025-06-02. The listed applicant is Acuity Surgical Devices, LLC. The 510(k) number is K251335.

When did Tera Lumbar Interbody Fusion System (Various PNs) receive FDA 510(k) clearance?

Tera Lumbar Interbody Fusion System (Various PNs) received FDA 510(k) clearance on 2025-06-02, under 510(k) number K251335.

Who is the listed applicant for Tera Lumbar Interbody Fusion System (Various PNs)?

The FDA 510(k) record lists Acuity Surgical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tera Lumbar Interbody Fusion System (Various PNs)?

The FDA product code for Tera Lumbar Interbody Fusion System (Various PNs) is MAX.

列明Acuity Surgical Devices, LLC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。

K251735Stabilis SA颈椎独立系统（各种PN）K243386Ventris 椎体间融合装置 K241413sagAlign 腰椎笼系统（多种产品编号）K230639Align 颈椎椎间盘融合系统 K222561Align K221535Align腰椎椎间融合系统

查看所有 8 个设备 →

相关器械（代码：MAX）

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。

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官方来源

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