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CABEZAS FEMORALES DE CERÁMICA, BIOLOX® DELTA. - COFEPRIS Registration 46C2019 SSA

Access comprehensive regulatory information for CABEZAS FEMORALES DE CERÁMICA, BIOLOX® DELTA. (CERAMIC FEMORAL HEADS, BIOLOX® DELTA.) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 46C2019 SSA and manufactured by BIOMET MÉXICO, S.A. DE C.V.. The device was registered on January 22, 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
46C2019 SSA
CABEZAS FEMORALES DE CERÁMICA, BIOLOX® DELTA.
COFEPRIS Analysis ID: 46C2019 SSA
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Product Use / Uso del Producto
Spanish

LAS CABEZAS FEMORALES DE CERÁMICA, BIOLOX® DELTA, SON COMPONENTES MODULARES QUE SIRVEN PARA ARTROPLASTÍAS TOTALES DE CADERA Y ESTÁN INDICADOS PARA LOS CASOS SIGUIENTES: • PACIENTES QUE SUFREN UN DOLOR INTENSO DE CADERA E INCAPACITACIÓN POR UNA ARTRITIS R

English

THE CERAMIC FEMORAL HEADS, BIOLOX® DELTA, ARE MODULAR COMPONENTS THAT SERVE FOR TOTAL HIP ARTHROPLASTY AND ARE INDICATED FOR THE FOLLOWING CASES: • PATIENTS SUFFERING FROM SEVERE HIP PAIN AND INCAPACITATION DUE TO ARTHRITIS R

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)
CABEZAS FEMORALES DE CERÁMICA.
Trade Name (English)
CERAMIC FEMORAL HEADS.
Registration Information
Analysis ID
46C2019 SSA
Registration Date
January 22, 2019
Manufacturer / Fabricante
Name (English)
BIOMET MÉXICO, S.A. DE C.V.