510(k) K261209 ยท MRW System, Facet Screw Spinal Device
Ion-L
| Applicant | SurGenTec, LLC, Boca Raton FL, US |
| Decision | Substantially Equivalent, Jun 11, 2026 |
| Received | Apr 13, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261209
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.