510(k) K920034 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC
| Applicant | Pfizer Hospital Products Group, Inc., Rutherford NJ, US |
| Decision | Substantially Equivalent, Mar 18, 1992 |
| Received | Jan 6, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920034
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2010 | Stryker Howmedica Osteonics Corp. Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No. 6632-5-600.
Made in Ireland;
Howmedica Osteonics;
325 Corporate Drive,
Mahwah, NJ 07430
Intended for primary or secondar Terminated |
JWH | None listed |
| Sep 21, 2007 | Stryker Howmedica Osteonics Corp. Duracon Total Knee Modular Femoral Component;
Non-Porous Right Medium Assembly, Product No. 6632-0-325 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.