510(k) K243865 ยท MRW System, Facet Screw Spinal Device
AERO MIS Facet Fusion System
| Applicant | Aurora Spine, Carlsbad CA, US |
| Decision | Substantially Equivalent, Mar 24, 2025 |
| Received | Dec 17, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243865
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.