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FDA 510(k)

Longeviti ClearFit OTS 颅骨植入物

K号: K231920 · 2023-11-09

申请人Longeviti Neuro Solutions, LLC
决定日期2023-11-09
产品代码GXN
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

Longeviti ClearFit OTS Cranial Implant is the device name listed in this FDA 510(k) record. The listed applicant is Longeviti Neuro Solutions, LLC. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K231920. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Longeviti ClearFit OTS Cranial Implant?

Longeviti ClearFit OTS Cranial Implant is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Longeviti Neuro Solutions, LLC. The 510(k) number is K231920.

When did Longeviti ClearFit OTS Cranial Implant receive FDA 510(k) clearance?

Longeviti ClearFit OTS Cranial Implant received FDA 510(k) clearance on 2023-11-09, under 510(k) number K231920.

Who is the listed applicant for Longeviti ClearFit OTS Cranial Implant?

The FDA 510(k) record lists Longeviti Neuro Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Longeviti ClearFit OTS Cranial Implant?

The FDA product code for Longeviti ClearFit OTS Cranial Implant is GXN.

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

列明Longeviti Neuro Solutions, 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。

K212058Longeviti ClearFit® OTS 颅骨植入物K211514Longeviti PorousFit 植入物K210616Longeviti PMMA 静态颅骨植入物K203349Longeviti ClearFit 颅骨植入物K202901Longeviti ClearFit 颅骨植入物K191210Longeviti ClearFit 颅骨植入物

查看所有 8 个设备 →

相关器械（代码：GXN）

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。

K260709ClearFit Ti 环 14mm (171750)；ClearFit Ti 环 14mm 带槽 (171751)；ClearFit Ti 环 20mm (171752)；ClearFit Ti 环 20mm 带槽 (171753)；ClearFit Ti 环 30mm (171754)Longeviti Neuro SolutionsK2531163D MAC 钛颅骨板 (TCP) 系统The Surgeon General, Department of the Army (TSG-DA)K252251EASYMADE-TICG Bio Co., Ltd.K252958METICULY 定制钛网状植入物Meticuly Co., Ltd.K243715Synthes患者特异性植入物Synthes GmbHK252573KLS Martin 颅骨植入物 - MR 条件；K944565：KLS-Martin 微型骨合成系统（1.5MM）；K971297：KLS Martin 中心驱动无钻螺丝；K060177：KLS Martin 刚性固定 - 无菌；K062570：个体化患者解决方案 - Ti (IPS-Ti)；K072707：个体化患者解决方案 - PEEK (IPS-PEEK)；K151382：个体化患者解决方案 - (IPS-PEEK) - 无菌KLS-Martin L.P.

官方来源

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