510(k) K140178 ยท PGN Growing Rod System- Magnetic Actuation
ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
| Applicant | Ellipse Technologies, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 27, 2014 |
| Received | Jan 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140178
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2019 | NuVasive Specialized Orthopedics, Inc. MAGEC 1 System Open, Classified |
PGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.