PGM · Class II · 21 CFR 888.3070

FDA Product Code PGM: Growing Rod System

Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion.

Leading manufacturers include Globus Medical, Inc. and OrthoPediatrics Corp..

2
Total
2
Cleared
355d
Avg days
2022
Since

List of Growing Rod System devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Mar 14, 2025
VerteGlide Spinal Growth Guidance System
K241816
OrthoPediatrics Corp.
Orthopedic · 263d
Cleared Dec 19, 2022
MARVEL™ Growing Rods
K213196
Globus Medical, Inc.
Orthopedic · 446d

How to use this database

This page lists all FDA 510(k) submissions for Growing Rod System devices (product code PGM). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →