510(k) K041001 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
OMEGA 2 SYSTEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Jul 1, 2004 |
| Received | Apr 19, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041001
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.