PGN
9 FDA 510(k) clearances · Product code
76 daysmedian time to decision
312 days90th percentile
9clearances measured
FDA profile
- Official device name
- Growing Rod System- Magnetic Actuation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA definition
- Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.
- Adverse events (MAUDE)
- 2019: 86 · 2020: 339 · 2021: 204 · 2022: 120 · 2023: 189 · 2024: 30
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MAGEC Spinal Bracing and Distraction System (K233593) | Nuvasive Specialized Orthopedics, Incorporated | 2024-02-06 |
| MAGEC® System (K201543) | Nuvasive Specialized Orthopedics, Inc. | 2020-07-30 |
| MAGEC® System (K171791) | Nuvasive Specialized Orthopedics, Incorporated | 2017-08-31 |
| MAGEC® Spinal Bracing and Distraction System (K160352) | Nuvasive Specialized Orthopedics, Inc. | 2016-10-21 |
| MAGEC® Spinal Bracing and Distraction System (K161751) | Nuvasive Specialized Orthopedics, Inc. | 2016-09-02 |
| MAGEC 2 Spinal Bracing and Distraction System (K150885) | Ellipse Technologies, Incorporated | 2015-05-29 |
| MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (K141278) | Ellipse Technologies, Inc. | 2015-03-24 |
| MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (K140613) | Ellipse Technologies, Inc. | 2014-09-18 |
| ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (K140178) | Ellipse Technologies, Inc. | 2014-02-27 |
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Every clearance here is in the API, with alerts when new ones post.