510(k) K043270 ยท HSB Rod, Fixation, Intramedullary And Accessories
SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES
| Applicant | Zimmer GmbH, Warsaw IN, US |
| Decision | Substantially Equivalent, Jan 31, 2005 |
| Received | Nov 26, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043270
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2012 | Zimmer, Inc. Sirus intramedullary nail for tibia, cannulated Terminated |
HSB | None listed |
| May 18, 2009 | Zimmer Inc. Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH, Winterthur, Switzerland; REF 02.02631.233.
The device is used in orthopedic trauma surgeries for s Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.