FDA 510(k)

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

K-Nummer: K253308 · 2026-01-07

Entscheidungsdatum2026-01-07

ProduktcodePPT

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Verwandte Geräte (Code: PPT)

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.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

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