510(k) K031438 ยท HSB Rod, Fixation, Intramedullary And Accessories
ACUMED SMALL BONE LOCKING ROD SYSTEM II
| Applicant | Acumed, LLC, Hillsboro OR, US |
| Decision | Substantially Equivalent, Jul 17, 2003 |
| Received | May 6, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031438
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2010 | Acumed LLC Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.