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FDA 510(k)

Materialise 针对颅面外科手术的个性化引导和模型 CMF 钛制引导；CMF 塑料模型

K号: K253308 · 2026-01-07

申请人Materialise NV
决定日期2026-01-07
产品代码PPT
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

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2026-01-07 under 510(k) number K253308. The device is classified under product code PPT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models?

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models is a medical device that received FDA 510(k) clearance on 2026-01-07. The listed applicant is Materialise NV. The 510(k) number is K253308.

When did Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models receive FDA 510(k) clearance?

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models received FDA 510(k) clearance on 2026-01-07, under 510(k) number K253308.

Who is the listed applicant for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models?

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

What is the FDA product code for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models?

The FDA product code for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models is PPT.

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Materialise NV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。

K260802Materialise肩关节系统™，Materialise肩关节引导和模型，SurgiCase肩关节规划器K251964Mimics 胸部规划器K253793Materialise全膝关节置换术引导系统K251554Materialise全膝关节置换术引导系统K243637Materialise 针对颅面外科手术的个性化引导和模型K242813Materialise肩关节系统™，Materialise肩关节引导和模型，SurgiCase肩关节规划器

查看所有 34 个设备 →

相关器械（代码：PPT）

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。

K201052KLS Martin 个体化患者解决方案 (IPS) 规划系统KLS-Martin L.P.K182889KLS Martin 个体化患者解决方案 (IPS) 规划系统KLS-Martin L.P.K151285VSP颅脑系统3D Systems, Inc.

官方来源

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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。

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