510(k) K033618 ยท HSB Rod, Fixation, Intramedullary And Accessories
SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Feb 5, 2004 |
| Received | Nov 18, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033618
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2013 | Synthes USA HQ, Inc. Synthes Trauma Nail System. The devices are indication for bone fixation. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.