FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
K Number: K253308
·
Decision Jan 7, 2026
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
3
Applicant Total
61
Review Days
100
Basic Information
- Device Name
- Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
- K Number
- K253308
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Materialise NV
- Date Received
- September 29, 2025
- Decision Date
- January 7, 2026
- Product Code
- PPT
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PPT | Cranial Surgical Planning And Instrument Guides | FDA class 2 | Neurology |
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