510(k) K936008 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
DURACON BASEPLATES
| Applicant | Howmedica Corp., Rutherford NJ, US |
| Decision | Substantially Equivalent for Some Indications, Aug 9, 1995 |
| Received | Dec 16, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K936008
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2024 | Howmedica Osteonics Corp. PRIMARY REV.TIB.INSERT-DURACON
Intended for knee replacement.
Product Number: 6637-4-031 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. LARGE PRIMARY REV.TIB.INSERT- DURACON
Intended for knee replacement
Product Number: 6637-4-231 Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.