Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models— 510(k) K253308
Substantially EquivalentMaterialise NV
FDA 510(k) clearance K253308 for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models, Substantially Equivalent on 2026-01-07. Applicant: Materialise NV.
Clearance details
- Applicant
- Materialise NV
- Product code
- Code PPT
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Leuven, BE
Data sourced from openFDA. This site is unofficial and independent of the FDA.