FDA 510(k)

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

N.º K: K243637 · 2025-02-21

Fecha de decisión2025-02-21

Código de productoDZJ

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Otros registros que enlistan a Materialise NV como solicitante

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner K251964Mimics Thoracic Planner K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models K253793Materialise TKA Guide System K251554Materialise TKA Guide System K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.