510(k) K833921 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
AGC TOTAL KNEE PROSTHESIS
| Applicant | Biomet, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 31, 1984 |
| Received | Nov 14, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K833921
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2017 | Zimmer Biomet, Inc. AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802.
Product Usage:
For use in Total Knee Arthroplasty. Terminated |
JWH | None listed |
| Aug 25, 2017 | Zimmer Biomet, Inc. AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804.
Product Usage:
For use in Total Knee Arthroplasty. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.