510(k) K132161 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Oct 11, 2013 |
| Received | Jul 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132161
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.