510(k) K182307 · HSB Rod, Fixation, Intramedullary And Accessories
Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Jan 14, 2019 |
| Received | Aug 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182307
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.