510(k) K253966 · NKB Thoracolumbosacral Pedicle Screw System
PERLA® TL Posterior Thoraco-lumbar Fixation System
| Applicant | Spineart SA, Plan-Les-Ouates, CH |
| Decision | Substantially Equivalent, May 1, 2026 |
| Received | Dec 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253966
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.