510(k) K123380 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
STRIDE UNICONDYLAR KNEE
| Applicant | Blue Belt Technologies, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, May 31, 2013 |
| Received | Nov 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123380
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2014 | Blue Belt Technologies MN Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis. Terminated |
HSX | None listed |
| Jun 27, 2014 | Blue Belt Technologies MN Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis. Terminated |
HSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.