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, 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
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.
PGN devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →