510(k) K253308
- Device
- Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
- Applicant
- Materialise NV
- 510(k) number
- K253308
- Product code
- PPT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-07
- Date received
- 2025-09-29
- Regulation
- 882.4310
- Classification name
- Cranial Surgical Planning And Instrument Guides
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Polliane Carvalho
- Address
- Technologielaan 15 Leuven BE 3001 3001
FDA Registration Numbers#
- 3003998208
- 3011724582
- 9610905
- 3009555440
- 3009555447
- 1057946
- 3005718816
- 1724955
- 3014483751
Source Documents#
Other 510(k) Records For Product Code PPT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201052 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2020-08-31 |
| K182889 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2019-07-26 |
| K151285 | VSP Cranial System | 3D Systems, Inc. | 2016-09-23 |