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FDA 510(k)

3D MAC 钛颅骨板 (TCP) 系统

K号: K253116 · 2026-06-18

申请人The Surgeon General, Department of the Army (TSG-DA)
决定日期2026-06-18
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

3D MAC Titanium Cranial Plate (TCP) System is the device name listed in this FDA 510(k) record. The listed applicant is The Surgeon General, Department of the Army (TSG-DA). It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253116. 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 3D MAC Titanium Cranial Plate (TCP) System?

3D MAC Titanium Cranial Plate (TCP) System is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is The Surgeon General, Department of the Army (TSG-DA). The 510(k) number is K253116.

When did 3D MAC Titanium Cranial Plate (TCP) System receive FDA 510(k) clearance?

3D MAC Titanium Cranial Plate (TCP) System received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253116.

Who is the listed applicant for 3D MAC Titanium Cranial Plate (TCP) System?

The FDA 510(k) record lists The Surgeon General, Department of the Army (TSG-DA) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D MAC Titanium Cranial Plate (TCP) System?

The FDA product code for 3D MAC Titanium Cranial Plate (TCP) System 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The Surgeon General, Department of the Army (TSG-DA)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。

K233249APPRAISE-HRI

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 SolutionsK252251EASYMADE-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.K240567定制骨服务Fin-Ceramica Faenza S.P.A.

官方来源

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