Panels › Orthopedic › Product code PGN · Class 2
Growing Rod System- Magnetic Actuation
Regulation 888.3070
0510(k)s in 12 months (9 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in PGN
| Company | 510(k)s | Recalls |
|---|---|---|
| Nuvasive Specialized Orthopedics, Inc. | 5 | 2 |
| Ellipse Technologies, Inc. | 4 | 0 |
| Globus Medical, Inc. | 0 | 1 |
| NuVasive Inc | 0 | 1 |
| 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 | K171791 |
| 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 | K201543 |
| 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 | K171791 |
| Jun 25, 2019 | NuVasive Specialized Orthopedics, Inc. MAGEC 1 System Open, Classified |
PGN | K140178 |
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