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. Device class: 2.
Clearance details
- Applicant
- Materialise NV
- Product code
- Code PPT
- Device class
- Class 2
- Regulation
- 21 CFR 882.4310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Leuven, BE
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