510(k) K090705 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT
| Applicant | Ortho Development Corp., Draper UT, US |
| Decision | Substantially Equivalent, Oct 9, 2009 |
| Received | Mar 17, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090705
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2014 | Ortho Development Corporation Tibila Insert UC, Balanced Knee System, REF163-3YYY
Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.