PGN
- Product code
- PGN
- Device name
- Growing Rod System- Magnetic Actuation
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3070
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 9
FDA classification definition
Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K233593 | 2024-02-06 | Nuvasive Specialized Orthopedics, Inco | MAGEC Spinal Bracing and Distraction System |
Official FDA classification page: PGN
Classification and pathway per current FDA publications. Data from openFDA (CC0).