FDA 510(k)

Longeviti PMMA 静态颅骨植入物

K号: K210616 · 2021-03-31

决定日期2021-03-31

产品代码GXN

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决定实质等同

器械摘要

Longeviti PMMA Static 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 2021-03-31 under 510(k) number K210616. 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 PMMA Static Cranial Implant?

Longeviti PMMA Static Cranial Implant is a medical device that received FDA 510(k) clearance on 2021-03-31. The listed applicant is Longeviti Neuro Solutions, LLC. The 510(k) number is K210616.

When did Longeviti PMMA Static Cranial Implant receive FDA 510(k) clearance?

Longeviti PMMA Static Cranial Implant received FDA 510(k) clearance on 2021-03-31, under 510(k) number K210616.

Who is the listed applicant for Longeviti PMMA Static 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 PMMA Static Cranial Implant?

The FDA product code for Longeviti PMMA Static Cranial Implant is GXN.

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。

K231920Longeviti ClearFit OTS 颅骨植入物 K212058Longeviti ClearFit® OTS 颅骨植入物 K211514Longeviti PorousFit 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 Solutions K2531163D 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 GmbH K252573KLS 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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