KLS-Martin L.P. · Class II · Cleared Nov 10, 2025
| K-number | K252573 |
| Device name | 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 (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE |
| Applicant | KLS-Martin L.P. |
| Product code | GXN |
| Device class | Class II |
| Decision date | Nov 10, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.5330 |
The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →
View the full FDA submission: accessdata.fda.gov