510(k) K260913 ยท DZJ Driver, Wire, And Bone Drill, Manual
CMF Titanium Splints
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Oct 9, 2026 |
| Received | Mar 19, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260913
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.