Members中文

PGM

Growing Rod System

Product code
PGM
Device name
Growing Rod System
Device class
Class 2
21 CFR
21 CFR 888.3070
Medical specialty
Orthopedic
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
14

FDA classification definition

Stabilization or correction of spinal deformities without the use of fusion.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-01-15.

NumberDecision dateApplicantDevice nameSummary
K2519612026-01-15BAAT Medical Products B.V.SDS Growing RodPDF
K2418162025-03-14OrthoPediatrics Corp.VerteGlide Spinal Growth Guidance SystemPDF

2 summaries are archived here for direct download.

Official FDA classification page: PGM
Classification and pathway per current FDA publications. Data from openFDA (CC0).