510(k) K252461 · NKB Thoracolumbosacral Pedicle Screw System
Swedge Pedicle Screw Fixation System Bezier Rod
| Applicant | Spinal Resources, Inc., Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Jan 13, 2026 |
| Received | Aug 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252461
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.