510(k) K223227 · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
MAVEN Patient-Specific Instrumentation
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Nov 17, 2022 |
| Received | Oct 18, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223227
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.