510(k) K012158 ยท HSB Rod, Fixation, Intramedullary And Accessories
MODIFICATION TO: LONG LENGTH GAMMA NAIL
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Aug 1, 2001 |
| Received | Jul 11, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012158
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.