510(k) K140649 ยท NDK System, External Fixator (With Metallic Invasive Components)
VECTRIX EXTERNAL FIXATOR
| Applicant | 3D Medical Concepts, LLC, Pelham AL, US |
| Decision | Substantially Equivalent, Dec 29, 2014 |
| Received | Mar 13, 2014 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K140649
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.