510(k) K192994 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Paragon 28 APEX 3D Total Ankle Replacement System
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Jul 10, 2020 |
| Received | Oct 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192994
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.