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FDA 510(k)

CMF Titanium Splints

K-Number: K260913 · 2026-10-09

ApplicantMaterialise NV
Decision Date2026-10-09
Product CodeDZJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CMF Titanium Splints is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2026-10-09 under 510(k) number K260913. 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 CMF Titanium Splints?

CMF Titanium Splints is a medical device that received FDA 510(k) clearance on 2026-10-09. The listed applicant is Materialise NV. The 510(k) number is K260913.

When did CMF Titanium Splints receive FDA 510(k) clearance?

CMF Titanium Splints received FDA 510(k) clearance on 2026-10-09, under 510(k) number K260913.

Who is the listed applicant for CMF Titanium Splints?

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 CMF Titanium Splints?

The FDA product code for CMF Titanium Splints is DZJ.

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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 SystemK243637Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

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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.K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NVK242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.K231520tmCMF SolutionTechmah CmfK230276TECHFIT DISRP® SystemTechfit Digital SurgeryK223024MedCAD AccuPlan SystemMedcad

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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