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 Ellipse Technologies, Inc., 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
Cleared
Feb 06, 2024
MAGEC Spinal Bracing and Distraction System
Nuvasive Specialized Orthopedics, Incorporated
Orthopedic
90d
Cleared
Jul 30, 2020
MAGEC® System
Nuvasive Specialized Orthopedics, Inc.
Orthopedic
51d
Cleared
Aug 31, 2017
MAGEC® System
Nuvasive Specialized Orthopedics, Incorporated
Orthopedic
76d
Cleared
Oct 21, 2016
MAGEC® Spinal Bracing and Distraction System
Nuvasive Specialized Orthopedics, Inc.
Orthopedic
256d
Cleared
Sep 02, 2016
MAGEC® Spinal Bracing and Distraction System
Nuvasive Specialized Orthopedics, Inc.
Orthopedic
70d
Cleared
May 29, 2015
MAGEC 2 Spinal Bracing and Distraction System
Ellipse Technologies, Incorporated
Orthopedic
57d
Cleared
Mar 24, 2015
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
Ellipse Technologies, Inc.
Orthopedic
312d
Cleared
Sep 18, 2014
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
Ellipse Technologies, Inc.
Orthopedic
192d
Cleared
Feb 27, 2014
ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
Ellipse Technologies, Inc.
Orthopedic
34d
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.