510(k) K012172 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
DURACON PS LIPPED TIBIAL INSERT
| Applicant | Howmedica Osteonics, Allendale NJ, US |
| Decision | Substantially Equivalent, Oct 10, 2001 |
| Received | Jul 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012172
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2024 | Howmedica Osteonics Corp. PS LIPPED TIBIAL INSERT ASSY DURACON
Intended for knee replacement
Product Number: 6742-1-411 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. PS LIPPED TIBIAL INSERT ASSY DURACON
Intended for knee replacement
Product Number: 6742-1-413 Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.