510(k) K243265 ยท MRW System, Facet Screw Spinal Device
Ion 3D
| Applicant | SurGenTec, LLC, Boca Raton FL, US |
| Decision | Substantially Equivalent, Dec 4, 2024 |
| Received | Oct 15, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243265
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.