Clearance Summary
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models received FDA 510(k) clearance under submission number K253308, sponsored by Materialise NV. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-01-07.
- Submission: K253308
- Applicant / Sponsor: Materialise NV
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4310
- Decision date: 2026-01-07
Classification & Regulation
This clearance is catalogued under FDA product code PPT and 21 CFR 882.4310, within the Neurology review panel as a Class II device.