510(k) K150890 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Exactech Optetrak Logic CC
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, May 29, 2015 |
| Received | Apr 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150890
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2024 | Exactech, Inc. Exactech Optetrak Logic Knee System, Catalog Numbers:
a) 02-012-47-3011,
b) 02-012-47-5009,
c) 02-012-47-5011,
d) 02-012-65-3013 Open, Classified |
JWH | None listed |
| Jan 27, 2020 | Exactech, Inc. Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and Open, Classified |
JWH | None listed |
| May 8, 2018 | Exactech, Inc. Optetrak Logic CC Stem Extension, 22mm x 160mm
The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due Open, Classified |
JWH | None listed |
| Jun 19, 2017 | Exactech, Inc. Exactech Optetrak Logic CC 15mm Tibial Augment Screws Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.