FDA 510(k)

ZSFab 颈椎椎间融合系统及 ZSFab 腰椎椎间融合系统

K号: K260549 · 2026-04-24

决定日期2026-04-24

产品代码ODP

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

ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Zsfab, Inc.. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K260549. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System?

ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Zsfab, Inc.. The 510(k) number is K260549.

When did ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System receive FDA 510(k) clearance?

ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System received FDA 510(k) clearance on 2026-04-24, under 510(k) number K260549.

Who is the listed applicant for ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System?

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

What is the FDA product code for ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System?

The FDA product code for ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System is ODP.

列明Zsfab, Inc.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。

K261451ZSAlign 颈椎椎间融合系统 K252610ZSFab 腰椎椎间融合系统 K232150ZSFab 颈椎椎间融合系统 K221858ZSFab 腰椎椎间融合系统 K202488ZSFab 颈椎椎间融合系统

相关器械（代码：ODP）

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。

K262595VariLift-C 颈椎椎间融合系统Wenzel Spine, Inc.K262489BluEX宫颈可扩张笼系统L&K BIOMED Co., Ltd.K2530413D颈椎笼Fims Co., Ltd.K262061Tritanium® C 前颈椎笼；Tritanium® PL笼；Tritanium® TL弯曲腰椎笼；Aero® -C 颈椎笼系统；AVS® Anchor-C 颈椎笼系统；AVS® TL PEEK间隔器；AVS® PL PEEK间隔器；AVS® 导航PEEK间隔器；AVS® AS PEEK间隔器；Monterey™ AL椎间系统；Aleutian IBF系统；Cascadia椎间系统；Chesapeake稳定系统；Sahara稳定系统；SANTORINI™ 脱位椎体笼系统；MOJAVE椎间系统；VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. 医疗椎间融合系统C.A. Medical, LLC K260840BluEX宫颈可扩张笼系统L&K BIOMED Co., Ltd.

官方来源

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