PGN · Class II · 21 CFR 888.3070

FDA Product Code PGN: Growing Rod System- Magnetic Actuation

Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion, Using Non-invasive Methods To Adjust The Spinal Rod.

Leading manufacturers include Nuvasive Specialized Orthopedics, Inc. and Nuvasive Specialized Orthopedics, Incorporated.

9
Total
9
Cleared
126d
Avg days
2014
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Growing Rod System- Magnetic Actuation Devices (Product Code PGN)

9 devices
1–9 of 9
Cleared Feb 06, 2024
MAGEC Spinal Bracing and Distraction System
K233593
Nuvasive Specialized Orthopedics, Incorporated
Orthopedic · 90d
Cleared Jul 30, 2020
MAGEC® System
K201543
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 51d

About Product Code PGN - Regulatory Context

510(k) Submission Activity

9 total 510(k) submissions under product code PGN since 2014, with 9 receiving FDA clearance (average review time: 126 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.