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FDA 510(k)

CREO® Stabilization System, REVERE® Stabilization System

K-Number: K181068 · 2018-06-29

ApplicantGlobus Medical, Inc.
Decision Date2018-06-29
Product CodePGM
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CREO® Stabilization System, REVERE® Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2018-06-29 under 510(k) number K181068. The device is classified under product code PGM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREO® Stabilization System, REVERE® Stabilization System?

CREO® Stabilization System, REVERE® Stabilization System is a medical device that received FDA 510(k) clearance on 2018-06-29. The listed applicant is Globus Medical, Inc.. The 510(k) number is K181068.

When did CREO® Stabilization System, REVERE® Stabilization System receive FDA 510(k) clearance?

CREO® Stabilization System, REVERE® Stabilization System received FDA 510(k) clearance on 2018-06-29, under 510(k) number K181068.

Who is the listed applicant for CREO® Stabilization System, REVERE® Stabilization System?

The FDA 510(k) record lists Globus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREO® Stabilization System, REVERE® Stabilization System?

The FDA product code for CREO® Stabilization System, REVERE® Stabilization System is PGM.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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