510(k) K012702 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1
| Applicant | Endotec, Inc., South Orange NJ, US |
| Decision | Substantially Equivalent, Jan 30, 2002 |
| Received | Aug 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012702
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2010 | Endotec, Inc. Endotec, Prosthesis Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, Titanium Alloy, Sterilized, (Beuchel-Pappas (BP))
The B-P Knee Replacement System is composed of sev Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.