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CREO Stabilization System, REVERE Stabilization System

by Globus Medical, Inc.

510(k) K181068

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181068 Date29 Jun 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
PGM
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Creo Stabilization System and Revere Stabilization System are orthopedic devices, specifically growing rod systems, used for thoracolumbar stabilization. They are designed to treat a range of spinal pathologies and posterior lumbar conditions. The systems offer a range of implants, including polyaxial screws, rods, and connectors, to provide convenience and ease of use in surgery.

The devices are supplied in various configurations, including a 5.5mm diameter rod, and are intended for use in orthopedic procedures. The systems have been authorized with an FDA 510K clearance, with a regulation number of 888.3070, and are classified as a class 2 device. The devices are manufactured by Globus Medical, Inc.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Creo Revere Stabilization System used for?

    The Creo Revere Stabilization System is used for thoracolumbar stabilization, treating a range of spinal pathologies and posterior lumbar conditions.

  • What implants are included in the system?

    The system includes a range of implants, such as polyaxial screws, rods, and connectors, to provide convenience and ease of use in surgery.

  • What is the diameter of the rod in the system?

    The system is supplied in various configurations, including a 5.5mm diameter rod.

  • What regulatory clearance has the system received?

    The system has received FDA 510K clearance, with a regulation number of 888.3070, and is classified as a class 2 device.