510(k) K254247 ยท NKB Thoracolumbosacral Pedicle Screw System
OSTEOMNI SPINAL FIXATION SYSTEM
| Applicant | Osteomni, Inc., Medley FL, US |
| Decision | Substantially Equivalent, Feb 24, 2026 |
| Received | Dec 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254247
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.