Product code PGN— Orthopedic
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
- Classification name
- Growing Rod System- Magnetic Actuation
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Total cleared
- 9
- First cleared
- Most recent
FDA classification definition
“Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.”
Market context for product code PGN
FDA has cleared devices under product code PGN between 2014 and 2024, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2024
- 2020
- 2017
- 2016
- 2015
- 2014
Top applicants under product code PGN
Adverse events under product code PGN
product code PGN- Injury
- 253
- Malfunction
- 633
- Total
- 886
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code PGN
- K233593 — MAGEC Spinal Bracing and Distraction System
- K201543 — MAGEC® System
- K171791 — MAGEC® System
- K160352 — MAGEC® Spinal Bracing and Distraction System
- K161751 — MAGEC® Spinal Bracing and Distraction System
- K150885 — MAGEC 2 Spinal Bracing and Distraction System
- K141278 — MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
- K140613 — MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
- K140178 — ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.