510(k) K140613 ยท PGN Growing Rod System- Magnetic Actuation
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
| Applicant | Ellipse Technologies, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 18, 2014 |
| Received | Mar 10, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140613
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.