510(k) K210390 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Apex 3D Total Ankle Replacement System
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Mar 6, 2021 |
| Received | Feb 9, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210390
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.