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STERNALOCK 360 - COFEPRIS Registration 1209C2019 SSA

Access comprehensive regulatory information for STERNALOCK 360 (STERNALOCK 360) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 1209C2019 SSA and manufactured by BIOMET MÉXICO, S.A. DE C.V.. The device was registered on June 10, 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
1209C2019 SSA
STERNALOCK 360
COFEPRIS Analysis ID: 1209C2019 SSA
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Product Use / Uso del Producto
Spanish

LOS IMPLANTES STERNALOCK 360, ESTÁN PREVISTOS PARA USARSE DURANTE LA ESTABILIZACIÓN Y FIJACIÓN DE FRACTURAS DEL ESTERNÓN QUE INCLUYEN FIJACIÓN ESTERNAL POSTERIOR A LA ESTERNOTOMÍA Y PROCEDIMIENTOS QUIRÚRGICOS RECONSTRUCTIVOS ESTERNALES PARA FACILITAR LA F

English

STERNALOCK 360 IMPLANTS ARE INTENDED FOR USE DURING STABILIZATION AND FIXATION OF STERNUM FRACTURES THAT INCLUDE POST-STERNOTOMY STERNAL FIXATION AND STERNAL RECONSTRUCTIVE SURGICAL PROCEDURES TO FACILITATE STERNAL FRACTURES.

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)
PLACAS PARA ESTABILIZACIÓN Y FIJACIÓN DE FRACTURAS DE ESTERNÓN
Trade Name (English)
PLATES FOR STABILIZATION AND FIXATION OF STERNUM FRACTURES
Registration Information
Analysis ID
1209C2019 SSA
Registration Date
June 10, 2019
Manufacturer / Fabricante
Name (English)
BIOMET MÉXICO, S.A. DE C.V.