510(k) K081127 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ACCIN TOTAL KNEE SYSTEM
| Applicant | Accelerated Innovation, LLC, Clifton NJ, US |
| Decision | Substantially Equivalent, Oct 17, 2008 |
| Received | Apr 21, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081127
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2015 | Arthrex, Inc. Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.