Submission Details
| 510(k) Number | K254162 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 22, 2025 |
| Decision Date | February 20, 2026 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
K254162 is an FDA 510(k) clearance for the KLS Martin Ixos System, submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on February 20, 2026, 60 days after receiving the submission on December 22, 2025. This device falls under the Orthopedic review panel.
| 510(k) Number | K254162 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 22, 2025 |
| Decision Date | February 20, 2026 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | — |
| Device Class | — |