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FDA 510(k)

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models

K-Number: K253308 · 2026-01-07

ApplicantMaterialise NV
Decision Date2026-01-07
Product CodePPT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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 PlannerK253793Materialise TKA Guide SystemK251554Materialise TKA Guide SystemK243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryK242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

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Related Devices (Code: PPT)

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.

K201052KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.K182889KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.K151285VSP Cranial System3D Systems, Inc.

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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