510(k) K111400 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Jul 28, 2011 |
| Received | May 19, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111400
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.