510(k) K253374 · SGL Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant
LimiFlex® Dynamic Sagittal Tether Instrument Set
| Applicant | Empirical Spine, Morgan Hill CA, US |
| Decision | Substantially Equivalent, Jun 16, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253374
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.