510(k) K253169 · NKB Thoracolumbosacral Pedicle Screw System
Duet Spinal Fixation System
| Applicant | Box Spine, LLC, Tulsa OK, US |
| Decision | Substantially Equivalent, Feb 23, 2026 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253169
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.