FDA 510(k)

ORTHROS® 后方稳定系统；ORTHROS® MIS 后方稳定系统

K号: K180980 · 2018-10-27

决定日期2018-10-27

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

ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies, LLC. It received FDA 510(k) clearance on 2018-10-27 under 510(k) number K180980. 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 ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System?

ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System is a medical device that received FDA 510(k) clearance on 2018-10-27. The listed applicant is Camber Spine Technologies, LLC. The 510(k) number is K180980.

When did ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System receive FDA 510(k) clearance?

ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System received FDA 510(k) clearance on 2018-10-27, under 510(k) number K180980.

Who is the listed applicant for ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System?

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

What is the FDA product code for ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System?

The FDA product code for ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System is NKB.

列明Camber Spine Technologies, 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。

K232256Alcantara Thoracolumbar Plate System K203503Camber 骶髂（SI）固定系统 K210595SPIRA-T 斜后腰椎间隙，SPIRA-P 后腰椎间隙 K191584FORTICO 前路颈椎固定系统 K180724SPIRA 开放矩阵 LLIF

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。