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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 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.

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. 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.

Other records listing Materialise NV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerK251964Mimics Thoracic PlannerK253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsK253793Materialise TKA Guide SystemK251554Materialise TKA Guide SystemK242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

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Related Devices (Code: DZJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261826VSP System (Titanium Palatal Splint)3D Systems, Inc.K242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.K231520tmCMF SolutionTechmah CmfK230276TECHFIT DISRP® SystemTechfit Digital SurgeryK223024MedCAD AccuPlan SystemMedcadK220366EmbedMed3D Lifeprints UK , Ltd.

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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