510(k) K234128 ยท HSB Rod, Fixation, Intramedullary And Accessories
Phantom Fibula Nail System
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Aug 22, 2024 |
| Received | Dec 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234128
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2025 | Paragon 28, Inc. Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S Open, Classified |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.