Cleared Traditional

CREO? Stabilization System, REVERE? Stabilization System

K181068 · Globus Medical, Inc. · Orthopedic
Jun 2018
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K181068 is an FDA 510(k) clearance for the CREO? Stabilization System, REVERE? Stabilization System, 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 June 29, 2018, 67 days after receiving the submission on April 23, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K181068 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2018
Decision Date June 29, 2018
Days to Decision 67 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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