510(k) K101338 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
NEWFIX EXTERNAL FIXATION SYSTEM
| Applicant | Technologia Y Diseno Industrial, S.A DE C.V, South Lyon MI, US |
| Decision | Substantially Equivalent, Mar 14, 2011 |
| Received | May 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101338
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.