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AEQUALIS REVERSED FRACTURE - COFEPRIS Registration 1178C2020 SSA

Access comprehensive regulatory information for AEQUALIS REVERSED FRACTURE (AEQUALIS REVERSED FRACTURE) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 1178C2020 SSA and manufactured by ISA HEALTH S.A. DE C.V.. The device was registered on September 01, 2020.

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
1178C2020 SSA
AEQUALIS REVERSED FRACTURE
COFEPRIS Analysis ID: 1178C2020 SSA
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Product Use / Uso del Producto
Spanish

ELIMPLANTEHUMERALAEQUALISREVERSED™FRACTURE ES UN COMPONENTE DE LAPRÓTESIS DE HOMBRO SEMI RESTRINGIDAAEQUALIS REVERSED™FRACTURE. DEBEUSARSEENASOCIACIÓNCONLOSIMPLANTESGLENOIDESAEQUALIS™REVERSEDOAEQUALISREVERSED II O AEQUALIS™ PERFORMREVERSED. EL IMPLANTE GLENOIDEO ESTÁCOMPUESTO POR UNA BASE CON TORNILLOSDE ANCLAJE Y UNA ESFERA. EL IMPLANTEHUMERAL CONSISTE EN UN VÁSTAGOMONOBLOQUE HUMERAL Y UN INSERTOARTICULAR ESPECIFICO CONGRUENTE CONESFERA GLENOIDEA.

English

THE EQUALISREVERSED FRACTURE IS A COMPONENT OF THE SEMI-RESTRICTED SHOULDER PROSTHESIS, EQUALIS REVERSED™™FRACTURE. THEY SHOULD BE USED IN ASSOCIATION WITH THE IMPLANTSGLENOIDESAEQUALIS REVERSEDOAEQUALISREVERSED II OR AEQUALIS™™ PERFORMREVERSED. THE GLENOID IMPLANT IS COMPOSED OF A BASE WITH ANCHORING SCREWS AND A SPHERE. THE IMPLANTEHUMERAL CONSISTS OF A HUMERAL MONOBLOCK STEM AND A SPECIFIC ARTICULAR INSERT CONGRUENT WITH GLENOID SPHERE.

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)
PRÓTESIS DE HOMBRO METALPOLIMERO SEMIRESTRINGIDACEMENTADA
Trade Name (English)
METALCEMENTED POLYMER SHOULDER PROSTHESIS
Registration Information
Analysis ID
1178C2020 SSA
Registration Date
September 01, 2020
Manufacturer / Fabricante
Name (English)
ISA HEALTH S.A. DE C.V.