510(k) K093360 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Jan 11, 2010 |
| Received | Oct 28, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093360
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2021 | Exactech, Inc. OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following:
a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX;
b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012- Open, Classified |
JWH | None listed |
| Sep 4, 2012 | Exactech, Inc. OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011.
There are three product sizes being recal Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.