510(k) K043431 ยท HSB Rod, Fixation, Intramedullary And Accessories
GAMMA3 NAIL SYSTEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Feb 16, 2005 |
| Received | Dec 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043431
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.