510(k) K152170 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Exactech Optetrak Logic Enhanced Assembly
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Sep 3, 2015 |
| Received | Aug 4, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152170
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2024 | Exactech, Inc. Exactech Truliant Knee System, Catalog Numbers:
a) 02-012-35-3509,
b) 02-022-35-1509,
c) 02-022-35-1513,
d) 02-022-35-3010,
e) 02-022-35-3509,
f) 02-022-35-3510,
g) 02-022-35-3511,
h) 02-022- Open, Classified |
JWH | None listed |
| Oct 4, 2021 | Exactech, Inc. TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following:
a. TRULIANT CR Tibial Inserts;
b. TRULIANT CR Slope + Tibial Inserts;
c. TRULIANT CR Slope ++ Tibial Inse Open, Classified |
JWH | None listed |
| Mar 13, 2019 | Exactech, Inc. Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030
Product Usage:
Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Kn Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.