K243637

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

510(k) number: K243637
Device name: Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
Applicant: Materialise NV BE
Product code: DZJ — Driver, Wire, And Bone Drill, Manual
Decision date: 2025-02-21
Date received: 2024-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Dental

Also available from FDA: K243637.pdf

Official FDA record: K243637

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