PYRAMESH® IMPLANT SYSTEM / SISTEMA DE IMPLANTES DE TITANIO PYRAMESH Y SU INSTRUMENTAL ASOCIADO / MEDTRONIC - INVIMA Registration 60a46ea9e855f749c7835efc8e7ebc61
Access comprehensive regulatory information for PYRAMESH® IMPLANT SYSTEM / SISTEMA DE IMPLANTES DE TITANIO PYRAMESH Y SU INSTRUMENTAL ASOCIADO / MEDTRONIC (PYRAMESH IMPLANT SYSTEM / PYRAMESH® TITANIUM IMPLANT SYSTEM AND ITS ASSOCIATED INSTRUMENTS / MEDTRONIC) in the Colombia medical device market through Pure Global AI's free database. This IIb medical device is registered under INVIMA analysis ID 60a46ea9e855f749c7835efc8e7ebc61 and manufactured by MEDTRONIC INC. The device was registered on October 27, 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.
EL DISPOSITIVO PYRAMESH® C TITANIUM MESH ES UN DISPOSITIVO IMPLANTABLE DE FORMA CILÍNDRICA CON EXTREMOS ABIERTOS Y UN NÚCLEO HUECO EN TODO SU EJE LONGITUDINAL._x000D_ LAS ABERTURAS EN FORMA DE PIRÁMIDE ESTÁN INTEGRADAS EN LA PARED DEL DISPOSITIVO. ESTAS ABERTURAS Y EL NÚCLEO HUECO PERMITEN COLOCAR MATERIAL DE INJERTO DENTRO DEL DISPOSITIVO PARA AYUDAR A LOGRAR UNA FUSIÓN SÓLIDA. LOS EXTREMOS CONTORNEADOS DEL DISPOSITIVO PYRAMESH® C TITANIUM MESH SIRVEN PARA AGARRAR LAS PLACAS FINALES SUPERIOR E INFERIOR, PERMITIENDO ASÍ LA RESISTENCIA A LA EXPULSIÓN. _x000D_ LOS IMPLANTES PYRAMESH® ESTAN PREVISTOS PARA REFORZAR LOS TEJIDOS OSEOS DEBILES EN CIRUGIA ORTOPEDICA ASI COMO EN CIRUGIA RECONSTRUCTIVA MAXILOFACIAL._x000D_ EL DISPOSITIVO PYRAMESH® C TITANIUM MESH ESTÁ DISEÑADO PARA USARSE CON SISTEMAS DE FIJACIÓN ESPINAL SUPLEMENTARIOS QUE HAN SIDO PREVIAMENTE ETIQUETADOS PARA SU USO EN LA COLUMNA TORÁCICA Y / O LUMBAR._x000D_ LA MALLA DE TITANIO PYRAMESH® C DEBE UTILIZARSE EN EL RAQUIS TORACOLUMBAR (T1-L5) PARA SUSTITUIR Y RESTABLECER EL ESPACIO DEL CUERPO VERTEBRAL DETERIORADO O AFECTADO A CAUSA DE UN TUMOR Y/O DE UNA FRACTURA. LA MALLA DE TITANIO PYRAMESH® C ESTÁ PREVISTA PARA UTILIZARSE JUNTAMENTE CON UN SISTEMA DE FIJACIÓN COMPLEMENTARIO._x000D_
THE PYRAMESH® C TITANIUM MESH DEVICE IS A CYLINDRICAL-SHAPED IMPLANTABLE DEVICE WITH OPEN ENDS AND A HOLLOW CORE ALONG ITS ENTIRE LONGITUDINAL._x000D_ AXIS THE PYRAMID-SHAPED OPENINGS ARE INTEGRATED INTO THE WALL OF THE DEVICE. THESE OPENINGS AND THE HOLLOW CORE ALLOW GRAFT MATERIAL TO BE PLACED INSIDE THE DEVICE TO HELP ACHIEVE A SOLID FUSION. THE CONTOURED ENDS OF THE PYRAMESH® C TITANIUM MESH DEVICE SERVE TO GRIP THE UPPER AND LOWER END PLATES, THUS ALLOWING FOR RESISTANCE TO EJECTION. _x000D_ PYRAMESH® IMPLANTS ARE INTENDED TO STRENGTHEN WEAK BONE TISSUES IN ORTHOPEDIC SURGERY AS WELL AS IN RECONSTRUCTIVE SURGERY MAXILOFACIAL._x000D_ THE PYRAMESH® C TITANIUM MESH DEVICE IS DESIGNED FOR USE WITH SUPPLEMENTAL SPINAL FIXATION SYSTEMS THAT HAVE BEEN PRE-LABELED FOR USE IN THE THORACIC SPINE AND/OR LUMBAR._x000D_ PYRAMESH® C TITANIUM MESH SHOULD BE USED IN THE THORACOLUMBAR SPINE (T1-L5) TO REPLACE AND RESTORE VERTEBRAL BODY SPACE THAT IS DAMAGED OR AFFECTED BY A TUMOR AND/OR FRACTURE. THE PYRAMESH® C TITANIUM MESH IS INTENDED TO BE USED IN CONJUNCTION WITH A COMPLEMENTARIO._x000D_ FASTENING SYSTEM