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SISTEMA INSPACE DE ORTHO-SPACE - COFEPRIS Registration 1181C2020 SSA

Access comprehensive regulatory information for SISTEMA INSPACE DE ORTHO-SPACE (ORTHO-SPACE INSPACE 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 1181C2020 SSA and manufactured by STRYKER Mร‰XICO, S.A. DE C.V.. The device was registered on September 02, 2020.

This page provides complete registration details including product type (V. SURGICAL AND HEALING MATERIALS), 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
1181C2020 SSA
SISTEMA INSPACE DE ORTHO-SPACE
COFEPRIS Analysis ID: 1181C2020 SSA
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Product Use / Uso del Producto
Spanish

SEUTILIZACOMOSEPARADORPARAREDUCIRLAFRICCIONENTREELACROMIONYLACABEZADEL HUMERAL O EL MANGUITO DE LOSROTADORES Y PERMITIR UN FACILDESLIZAMIENTO DE LA CABEZA HUMERALCONTRA EL ACROMION

English

IT IS USED AS A SEPARATOR TO REDUCE FRICTION BETWEEN THE HUMERAL HEAD AND THE HUMERAL HEAD OR ROTATOR CUFF AND TO ALLOW EASY SLIDING OF THE HUMERAL HEAD AGAINST THE ACROMION

Device Classification
Risk Class / Clase de Riesgo
Clase III
Product Type (Spanish)
V. MATERIALES QUIRรšRGICOS Y DE CURACIร“N
Product Type (English)
V. SURGICAL AND HEALING MATERIALS
Trade Name (Spanish)
BALON ESPACIADOR
Trade Name (English)
SPACER BALLOON
Registration Information
Analysis ID
1181C2020 SSA
Registration Date
September 02, 2020
Manufacturer / Fabricante
Name (English)
STRYKER MEXICO, S.A. DE C.V.