510(k) K031201 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM
| Applicant | Ortho Development Corp., Draper UT, US |
| Decision | Substantially Equivalent, Jul 15, 2003 |
| Received | Apr 16, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031201
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2010 | Ortho Development Corporation 10 degree Tibial Augment Wedge, a component of Ortho Balanced Knee Modular Tibial System.
The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from Terminated |
JWH | None listed |
| Apr 5, 2010 | Ortho Development Corporation 5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System.
The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from sever Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.