510(k) K223252 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Jul 17, 2023 |
| Received | Oct 21, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223252
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2024 | Exactech, Inc. Exactech Truliant, Activit-E Knee Insert, Catalog Numbers:
a) 02-023-02-0029,
b) 02-023-02-0032,
c) 02-023-02-0035,
d) 02-023-02-0038,
e) 02-024-35-1512,
f) 02-024-35-1515,
g) 02-024-35-1519, Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.