510(k) K071738 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Aug 15, 2007 |
| Received | Jun 26, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071738
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2013 | Exactech, Inc. Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508. Terminated |
JWH | None listed |
| Aug 21, 2012 | Exactech, Inc. OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508.
The Optetrak Comprehens Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.