510(k) K260913
K260913 is an FDA 510(k) premarket notification submitted by Materialise NV for the device "CMF Titanium Splints". The FDA issued a decision of Substantially Equivalent on Oct 9, 2026. 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 61 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 9, 2026
- Date Received
- Mar 19, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Driver, Wire, And Bone Drill, Manual
- Device Class
- Class II
- Regulation Number
- 872.4120
- Review Panel
- DE
- Submission Type
- 510(k)