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CAPSTONE PTC™ SPINAL SYSTEM - COFEPRIS Registration 1845C2019 SSA

Access comprehensive regulatory information for CAPSTONE PTC™ SPINAL SYSTEM (CAPSTONE PTC™ SPINAL SYSTEM) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 1845C2019 SSA and manufactured by MEDTRONIC, S. DE R.L. DE C.V.. The device was registered on September 12, 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
1845C2019 SSA
CAPSTONE PTC™ SPINAL SYSTEM
COFEPRIS Analysis ID: 1845C2019 SSA
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Product Use / Uso del Producto
Spanish

EL SISTEMA VERTEBRAL CAPSTONE PTC™ ESTÁ INDICADO PARA LA ARTRODESIS INTERSOMÁTICA CON AUTOINJERTO ÓSEO EN PACIENTES CON ENFERMEDAD DISCAL DEGENERATIVA (EDD) EN UNO O DOS NIVELES ENTRE L2 Y S1. ESTOS PACIENTES CON EDD TAMBIÉN PUEDEN PRESENTAR ESPONDILOLIST

English

THE CAPSTONE PTC™ VERTEBRAL SYSTEM IS INDICATED FOR INTERBODY FUSION WITH BONE AUTOGRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (EDD) AT ONE OR TWO LEVELS BETWEEN L2 AND S1. THESE PATIENTS WITH EDD MAY ALSO HAVE ESPONDYLOLIST

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)
DISPOSITIVO DE FUSIÓN INVERTEBRAL
Trade Name (English)
INVERTEBRAL FUSION DEVICE
Registration Information
Analysis ID
1845C2019 SSA
Registration Date
September 12, 2019
Manufacturer / Fabricante
Name (English)
MEDTRONIC, S. DE R.L. DE C.V.