510(k) K252573 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (I
| Applicant | KLS-Martin L.P., Jacksonville FL, US |
| Decision | Substantially Equivalent, Nov 10, 2025 |
| Received | Aug 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252573
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.