510(k) K243637

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery by Materialise NV — Product Code DZJ

K243637 is an FDA 510(k) premarket notification submitted by Materialise NV for the device "Materialise Personalized Guides and Models for Craniomaxillofacial Surgery". The FDA issued a decision of Substantially Equivalent on February 21, 2025. The device falls under product code DZJ (Driver, Wire, And Bone Drill, Manual), a Class II device regulated under 21 CFR 872.4120. Materialise NV has at least 10 other 510(k) clearances on record.