510(k) K253308 ยท PPT Cranial Surgical Planning And Instrument Guides
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Jan 7, 2026 |
| Received | Sep 29, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253308
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.