FDA 510(k)

CREO® Stabilization System, REVERE® Stabilization System

N.º K: K181068 · 2018-06-29

Fecha de decisión2018-06-29

Código de productoPGM

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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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Otros registros que enlistan a Globus Medical, Inc. como solicitante

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Fuente oficial

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