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FDA 510(k)

脊柱对齐解决方案骨盆入口（PI）棒系统

K号: K242350 · 2024-10-28

申请人Spinal Alignment Solutions, Inc.
决定日期2024-10-28
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

Spinal Alignment Solutions Pelvic Incidence (PI) Rod System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Alignment Solutions, Inc.. It received FDA 510(k) clearance on 2024-10-28 under 510(k) number K242350. 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 Spinal Alignment Solutions Pelvic Incidence (PI) Rod System?

Spinal Alignment Solutions Pelvic Incidence (PI) Rod System is a medical device that received FDA 510(k) clearance on 2024-10-28. The listed applicant is Spinal Alignment Solutions, Inc.. The 510(k) number is K242350.

When did Spinal Alignment Solutions Pelvic Incidence (PI) Rod System receive FDA 510(k) clearance?

Spinal Alignment Solutions Pelvic Incidence (PI) Rod System received FDA 510(k) clearance on 2024-10-28, under 510(k) number K242350.

Who is the listed applicant for Spinal Alignment Solutions Pelvic Incidence (PI) Rod System?

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

What is the FDA product code for Spinal Alignment Solutions Pelvic Incidence (PI) Rod System?

The FDA product code for Spinal Alignment Solutions Pelvic Incidence (PI) Rod System is NKB.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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 SirketiK262193RIVA® 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 MedicalK262828KHEIRON®脊柱固定系统，包括患者专用K-RODS.M.A.I.OK260362QUATTRO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

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