510(k) K253545 ยท NKB Thoracolumbosacral Pedicle Screw System
Vulcan Spinal System
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Feb 10, 2026 |
| Received | Nov 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253545
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.