510(k) K060569 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM
| Applicant | Ortho Development Corp., Draper UT, US |
| Decision | Substantially Equivalent, Jul 6, 2006 |
| Received | Mar 3, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060569
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2014 | Ortho Development Corporation Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY
Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the fem Terminated |
JWH | None listed |
| Jan 7, 2011 | Ortho Development Corporation UC Tibial Insert, Size 4, 13mm, REF 163-3413, Sterile R, Ortho Development, Draper, Utah 84020.
The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base Terminated |
JWH | None listed |
| Jan 7, 2011 | Ortho Development Corporation CR Tibial Insert, Size 5, 7mm, REF 163-2507, Sterile R, Ortho Development, Draper, Utah 84020.
The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base Terminated |
JWH | None listed |
| Jan 7, 2011 | Ortho Development Corporation UC Tibial Insert, Size 4, 12mm, REF 163-3412, Sterile R, Ortho Development, Draper, Utah 84020
The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.