510(k) K040749 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
MODULAR REPLACEMENT SYSTEM CEMENTED STEMS
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Jun 17, 2004 |
| Received | Mar 23, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040749
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2009 | Stryker Howmedica Osteonics Corp. Modular Replacement System (MRS) Cemented Stems, Sterile, Catalog Numbers: 6485-3-000, 6485-3-008, 6485-3-009, 6485-3-010, 6485-3-018, 6485-3-019, 6485-3-300, 6485-3-308, 6485-3-309, 6485-3-310, 6485- Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.