510(k) K171791 · PGN Growing Rod System- Magnetic Actuation
MAGEC® System
| Applicant | Nuvasive Specialized Orthopedics, Incorporated, Alisa Viejo CA, US |
| Decision | Substantially Equivalent, Aug 31, 2017 |
| Received | Jun 16, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171791
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2025 | Globus Medical, Inc. MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; Open, Classified |
PGN | None listed |
| Feb 13, 2020 | NuVasive Inc NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spinal rod that is surgically implanted using appropriate NuVasive Reline, Reline Terminated |
PGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.