Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
FDA 510(k) clearance K253308 · decided 2026-01-07
Clearance details
- K-number
- K253308
- Device name
- Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
- Applicant
- Materialise NV
- Decision
- Substantially Equivalent
- Date received
- 2025-09-29
- Decision date
- 2026-01-07
- Days to decision
- 100 days
- Clearance type
- Special
- Product code
- PPT
- Device class
- 2
- Regulation number
- 882.4310
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Leuven, BE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| KLS Martin Individual Patient Solutions (IPS) Planning System (K201052) | KLS-Martin L.P. | 2020-08-31 |
| KLS Martin Individual Patient Solutions (IPS) Planning System (K182889) | KLS-Martin L.P. | 2019-07-26 |
| VSP Cranial System (K151285) | 3D Systems, Inc. | 2016-09-23 |
Recalls involving this device
No recalls on record reference this clearance.