510(k) K242827 · NKB Thoracolumbosacral Pedicle Screw System
A8 INTEGR8 Porous Pedicle Screws
| Applicant | Allumin8, Inc., Springfield MO, US |
| Decision | Substantially Equivalent, Oct 20, 2025 |
| Received | Sep 18, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242827
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.