510(k) K254274 · NKB Thoracolumbosacral Pedicle Screw System
ARx® SAI Implant System
| Applicant | Life Spine, Inc., Huntley IL, US |
| Decision | Substantially Equivalent, Apr 16, 2026 |
| Received | Dec 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254274
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.