510(k) K970897 ยท HSB Rod, Fixation, Intramedullary And Accessories
BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
| Applicant | Biodynamic Technologies, Inc., Deerfield Beach FL, US |
| Decision | Substantially Equivalent, Apr 21, 1997 |
| Received | Mar 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970897
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.