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FDA 510(k)

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

K-Number: K243637 · 2025-02-21

ApplicantMaterialise NV
Decision Date2025-02-21
Product CodeDZJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Materialise NV. The 510(k) number is K243637.

When was Materialise Personalized Guides and Models for Craniomaxillofacial Surgery approved by the FDA?

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

What company makes Materialise Personalized Guides and Models for Craniomaxillofacial Surgery?

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery is manufactured by Materialise NV.

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966058 Artificial intelligence in personalized prescription: A narrative review of promise, peril, and practicality. Therapie (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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