K253308

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

510(k) number: K253308
Device name: Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
Applicant: Materialise NV BE
Product code: PPT — Cranial Surgical Planning And Instrument Guides
Decision date: 2026-01-07
Date received: 2025-09-29
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Neurology

Also available from FDA: K253308.pdf

Official FDA record: K253308

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.