FDA 510(k)

SCRIPT® 杆，CREO® 稳定系统，REVERE® 稳定系统，REVERE® 4.5 稳定系统，NuVasive Reline® 系统

K号: K253739 · 2026-05-07

决定日期2026-05-07

产品代码NKB

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

SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2026-05-07 under 510(k) number K253739. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System?

SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System is a medical device that received FDA 510(k) clearance on 2026-05-07. The listed applicant is Globus Medical, Inc.. The 510(k) number is K253739.

When did SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System receive FDA 510(k) clearance?

SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System received FDA 510(k) clearance on 2026-05-07, under 510(k) number K253739.

Who is the listed applicant for SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System?

FDA 510(k)记录中列出Globus Medical, Inc.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 SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System?

The FDA product code for SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System is NKB.

列明Globus Medical, 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。

K254043TRIVANCE™ 髋关节假体 K262251ACTIFY™ 全膝关节系统，ACTIFY™ 3D 全膝关节系统（ACTIFY MC 胫骨植入物）K253401SCRIPT® 假体系统 K261043AUTOBAHN™ 钉钉系统 K252166RIB LINK™ 固定系统 K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)

查看所有 92 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。