510(k) K140158 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
S.E.A.L. FRACTURE FUSION TUBE
| Applicant | Dne, LLC, Round Rock TX, US |
| Decision | Substantially Equivalent, May 29, 2014 |
| Received | Jan 22, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140158
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.