FDA 510(k)

Materialise 针对颅面外科手术的个性化引导和模型

K号: K243637 · 2025-02-21

决定日期2025-02-21

产品代码DZJ

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决定实质等同

器械摘要

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2025-02-21 under 510(k) number K243637. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Materialise Personalized Guides and Models for Craniomaxillofacial Surgery?

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery is a medical device that received FDA 510(k) clearance on 2025-02-21. The listed applicant is Materialise NV. The 510(k) number is K243637.

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

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery received FDA 510(k) clearance on 2025-02-21, under 510(k) number K243637.

Who is the listed applicant for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery?

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?

The FDA product code for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery is DZJ.

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 K253308Materialise 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 K253793Materialise全膝关节置换术引导系统 K251554Materialise全膝关节置换术引导系统 K242813Materialise肩关节系统™，Materialise肩关节引导和模型，SurgiCase肩关节规划器

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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。