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CLYDESDALE ® SPINAL SYSTEM - INVIMA Registration 38d6faa91c4e699e664cb5dec40597f5

Access comprehensive regulatory information for CLYDESDALE ® SPINAL SYSTEM (CLYDESDALE ® SPINAL SYSTEM) in the Colombia medical device market through Pure Global AI's free database. This IIb medical device is registered under INVIMA analysis ID 38d6faa91c4e699e664cb5dec40597f5 and manufactured by MEDTRONIC INC. The device was registered on October 19, 2033.

This page provides complete registration details including product type (SURGICAL DOCTOR), authorised information, and regulatory compliance data from the official Colombia INVIMA medical device database. Pure Global AI offers free access to Colombia's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate INVIMA regulations efficiently.

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INVIMA Official Data
IIb
38d6faa91c4e699e664cb5dec40597f5
CLYDESDALE ® SPINAL SYSTEM
INVIMA Analysis ID: 38d6faa91c4e699e664cb5dec40597f5
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Product Use / Uso del Producto
Spanish

EL SISTEMA VERTEBRAL CLYDESDALE® SON IMPLANTES QUE PUEDEN INSERTARSE ENTRE DOS CUERPOS VERTEBRALES LUMBARES O LUMBOSACROS PARA PROPORCIONAR SOPORTE Y UN EFECTO CORRECTOR DURANTE LAS INTERVENCIONES DE ARTRODESIS INTERSOMÁTICA A NIVEL LUMBAR Y SE PRETENDEN PARA UTILIZACIÓN COMO FIJACIÓN SUPLEMENTARIA. EL SISTEMA CLYDESDALE® ESTÁ INDICADO PARA SER UTILIZADO EN COMBINACIÓN CON INJERTO DE HUESO AUTÓLOGO PARA PROCEDIMIENTOS DE FUSIÓN INTERSOMÁTICA VERTEBRAL EN PACIENTES CON ENFERMEDAD DEGENERATIVA DISCAL (EDD- DEFINIDA COMO DOLOR DE ESPALDA DE ORIGEN DISCOGÉNICO CON DEGENERACIÓN DISCAL CONFIRMADA POR EL HISTORIAL DE PACIENTE Y ESTUDIOS RADIOLÓGICOS) EN UNO O DOS NIVELES DESDE L2 HASTA S1.

English

THE CLYDESDALE® VERTEBRAL SYSTEM ARE IMPLANTS THAT CAN BE INSERTED BETWEEN TWO LUMBAR OR LUMBOSACRAL VERTEBRAL BODIES TO PROVIDE SUPPORT AND A CORRECTIVE EFFECT DURING INTERBODY FUSION INTERVENTIONS AT THE LUMBAR LEVEL AND ARE INTENDED FOR USE AS SUPPLEMENTARY FIXATION. THE CLYDESDALE® SYSTEM IS INDICATED TO BE USED IN COMBINATION WITH AUTOLOGOUS BONE GRAFTING FOR VERTEBRAL INTERBODY FUSION PROCEDURES IN PATIENTS WITH DEGENERATIVE DISC DISEASE (EDD- DEFINED AS BACK PAIN OF DISCOGENIC ORIGIN WITH DISC DEGENERATION CONFIRMED BY PATIENT HISTORY AND RADIOLOGICAL STUDIES) AT ONE OR TWO LEVELS FROM L2 TO S1.

Device Classification
Risk Class / Clase de Riesgo
IIb
Product Type (Spanish)
MEDICO QUIRURGICOS
Product Type (English)
SURGICAL DOCTOR
Registration Information
Analysis ID
38d6faa91c4e699e664cb5dec40597f5
Expire Date
October 19, 2033
Authorized Company / Fabricante
Name (Spanish)
MEDTRONIC INC
Name (English)
MEDTRONIC INC