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ELLIPSE® - COFEPRIS Registration 1753C2019 SSA

Access comprehensive regulatory information for ELLIPSE® (ELLIPSE®) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 1753C2019 SSA and manufactured by ISA HEALTH, S.A DE C.V.. The device was registered on August 27, 2019.

This page provides complete registration details including product type (II. PROSTHETICS, ORTHOSES AND FUNCTIONAL AIDS), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.

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COFEPRIS Official Data
Clase III
1753C2019 SSA
ELLIPSE®
COFEPRIS Analysis ID: 1753C2019 SSA
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Product Use / Uso del Producto
Spanish

EL SISTEMA DE COLUMNA OCCIPITO-CÉRVICO-TORÁCICO ELLIPSE® SE HA CREADO PARA SU UTILIZACIÓN CON PACIENTES DE ESQUELETO MADURO COMO ADJUNTO A LA FUSIÓN MEDIANTE AUTOINJERTO O ALOINJERTO, CON EL FIN DE ESTABILIZAR LA REGIÓN CERVICAL DE LA COLUMNA Y LA UNIÓN O

English

THE ELLIPSE® OCCIPITO-CERVICO-THORACIC SPINE SYSTEM HAS BEEN DEVELOPED FOR USE WITH PATIENTS WITH A MATURE SKELETON AS AN ADJUNCT TO FUSION BY AUTOGRAFT OR ALLOGRAFT, IN ORDER TO STABILIZE THE CERVICAL REGION OF THE SPINE AND THE JUNCTION OR

Device Classification
Risk Class / Clase de Riesgo
Clase III
Product Type (Spanish)
II. PROTESIS, ÓRTESIS Y AYUDAS FUNCIONALES
Product Type (English)
II. PROSTHETICS, ORTHOSES AND FUNCTIONAL AIDS
Trade Name (Spanish)
SISTEMA ESPINAL OCCIPITO-CÉRVICO-TORÁCICO
Trade Name (English)
OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM
Registration Information
Analysis ID
1753C2019 SSA
Registration Date
August 27, 2019
Manufacturer / Fabricante
Name (English)
ISA HEALTH, S.A DE C.V.