510(k) K201543 · PGN Growing Rod System- Magnetic Actuation
MAGEC® System
| Applicant | Nuvasive Specialized Orthopedics, Inc., Alisa Viejo CA, US |
| Decision | Substantially Equivalent, Jul 30, 2020 |
| Received | Jun 9, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201543
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2022 | NuVasive Specialized Orthopedics, Inc. NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis.
REF Model Numbers/NSO Item #/Product Description
MC2-4590S / PA0684 Open, Classified |
PGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.