510(k) K253308
K253308 is an FDA 510(k) premarket notification submitted by Materialise NV for the device "Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models". The FDA issued a decision of Substantially Equivalent on January 7, 2026. The device falls under product code PPT (Cranial Surgical Planning And Instrument Guides), a Class II device regulated under 21 CFR 882.4310. Materialise NV has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2026
- Date Received
- September 29, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cranial Surgical Planning And Instrument Guides
- Device Class
- Class II
- Regulation Number
- 882.4310
- Review Panel
- NE
- Submission Type
Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures.