510(k) K043570 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD
| Applicant | Conformis, Inc., Foster City CA, US |
| Decision | Substantially Equivalent, Mar 14, 2005 |
| Received | Dec 27, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043570
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2009 | Conformis Inc ConforMIS iUni ( Unicondylar Knee System ) Left Medial Implant Kit Product Code: M57220600010.
For cemented use only. System consists of femoral and tibial components. The femoral component is C Terminated |
HSX | None listed |
| Jul 15, 2009 | Conformis Inc ConforMIS iUni ( Unicondylar Knee System ) iUni Right Medial Implant Kit Product Code : M57220600020.
For cemented use only. System consists of femoral and tibial components. The femoral component Terminated |
HSX | None listed |
| Jul 15, 2009 | Conformis Inc ConforMIS iUni ( Unicondylar Knee System iUni Right Lateral Implant Kit Product Code: M57220600040.
For cemented use only. System consists of femoral and tibial components. The femoral component is Terminated |
HSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.