FDA 510(k)

FortiVy® OsteoVy® 腰椎间体融合器

K号: K241783 · 2025-03-18

决定日期2025-03-18

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

FortiVy™ OsteoVy™ Lumbar IBF is the device name listed in this FDA 510(k) record. The listed applicant is Vy Spine, LLC. It received FDA 510(k) clearance on 2025-03-18 under 510(k) number K241783. 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 FortiVy™ OsteoVy™ Lumbar IBF?

FortiVy™ OsteoVy™ Lumbar IBF is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is Vy Spine, LLC. The 510(k) number is K241783.

When did FortiVy™ OsteoVy™ Lumbar IBF receive FDA 510(k) clearance?

FortiVy™ OsteoVy™ Lumbar IBF received FDA 510(k) clearance on 2025-03-18, under 510(k) number K241783.

Who is the listed applicant for FortiVy™ OsteoVy™ Lumbar IBF?

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

What is the FDA product code for FortiVy™ OsteoVy™ Lumbar IBF?

The FDA product code for FortiVy™ OsteoVy™ Lumbar IBF is MAX.

列明Vy Spine, 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。

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查看所有 21 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。

K261049SCALA® TLSpineart SA K261430TruLift可扩展系统Life Spine, Inc.K253011Catalyft PL 可扩张椎间系统Medtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L 脊柱系统Medtronic Sofamor Danek USA, Inc.K253420Admiral ACP系统；Explorer TO系统；Laminoplasty系统；Manta Ray TDF间隔器；Meridian椎间系统；Meridian前板系统；Reef L椎间系统；Reef TO/TA系统；Regatta L侧系统；Regatta L侧板系统；Shoreline ACS椎间系统；Shoreline螺纹TruProfile板；Shoreline RT椎间系统；Vu网格；WaveForm A椎间系统；WaveForm C椎间系统；WaveForm L椎间系统；WaveForm TA椎间系统；WaveForm TO椎间系统SeaSpine Orthopedics Corporation K253151富乐椎间融合笼系统Beijing Fule Science & Technology Development Co., Ltd.

官方来源

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