Cleared Traditional

K241816 - VerteGlide Spinal Growth Guidance System
(FDA 510(k) Clearance)

K241816 · OrthoPediatrics Corp. · Orthopedic device

Mar 2025

Decision

263d

Days

Class 2

Risk

K241816 is an FDA 510(k) clearance for the VerteGlide Spinal Growth Guidance System. This device is classified as a Growing Rod System (Class II - Special Controls, product code PGM).

Submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on March 14, 2025, 263 days after receiving the submission on June 24, 2024.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070. Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion..

Submission Details

510(k) Number	K241816 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 24, 2024
Decision Date	March 14, 2025
Days to Decision	263 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PGM — Growing Rod System
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion.