FDA 510(k)

阈值椎弓根固定系统，栅栏椎弓根固定系统

K号: K160980 · 2016-05-26

决定日期2016-05-26

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

Threshold Pedicular Fixation System, Palisade Pedicular Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Spineology, Inc.. It received FDA 510(k) clearance on 2016-05-26 under 510(k) number K160980. 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 Threshold Pedicular Fixation System, Palisade Pedicular Fixation System?

Threshold Pedicular Fixation System, Palisade Pedicular Fixation System is a medical device that received FDA 510(k) clearance on 2016-05-26. The listed applicant is Spineology, Inc.. The 510(k) number is K160980.

When did Threshold Pedicular Fixation System, Palisade Pedicular Fixation System receive FDA 510(k) clearance?

Threshold Pedicular Fixation System, Palisade Pedicular Fixation System received FDA 510(k) clearance on 2016-05-26, under 510(k) number K160980.

Who is the listed applicant for Threshold Pedicular Fixation System, Palisade Pedicular Fixation System?

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

What is the FDA product code for Threshold Pedicular Fixation System, Palisade Pedicular Fixation System?

The FDA product code for Threshold Pedicular Fixation System, Palisade Pedicular Fixation System is NKB.

列明Spineology, 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。

K251302OptiMesh 多平面可扩张椎间融合系统 K251943Spineology Navigation Instruments K230927OptiMesh 多平面可扩张椎间融合系统 K231781OptiMesh 多平面可扩张椎间融合系统 K213876Spineology Navigation Instruments K210155Duo 可扩张椎间融合系统

查看所有 32 个设备 →

相关器械（代码：NKB）

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。

K252139肯特罗斯宾 Viktr-MIS® 椎弓根螺钉系统Rivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™植入系统SI-BONE, Inc.K262091FRAXION 脊柱固定系统Ortler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® 后固定系统，配备NanoACTIV表面技术；RIVA® 锚定骶髂固定系统，配备NanoACTIV表面技术Xenix Medical K262828KHEIRON®脊柱固定系统，包括患者专用K-RODS.M.A.I.O K260362QUATTRO脊柱系统（开放配置）；QUATTRO-GADGET脊柱系统（微创配置）MANTIZ Co., Ltd.

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。