510(k) K253472 · PQC Pedicle Screw Placement Guide
FIREFLY® Pedicle Screw Navigation Guide
| Applicant | Mighty Oak Medical, Englewood CO, US |
| Decision | Substantially Equivalent, Feb 25, 2026 |
| Received | Oct 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253472
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.