510(k) K951740 ยท HSB Rod, Fixation, Intramedullary And Accessories
INTRAMEDULARY FIXATION ROD
| Applicant | Acu Med, Inc., Beaverton OR, US |
| Decision | Substantially Equivalent, Aug 11, 1995 |
| Received | Mar 24, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951740
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2012 | Acumed LLC The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for humeral fractures. It is sealed in an internal sterile blister pack within a box that is label Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.