Cleared Traditional

MARVEL? Growing Rods

K213196 · Globus Medical, Inc. · Orthopedic
Dec 2022
Decision
446d
Days
Class 2
Risk

About This 510(k) Submission

K213196 is an FDA 510(k) clearance for the MARVEL? Growing Rods, a Growing Rod System (Class II — Special Controls, product code PGM), submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on December 19, 2022, 446 days after receiving the submission on September 29, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K213196 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2021
Decision Date December 19, 2022
Days to Decision 446 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.

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