SPIRA®-CINTEGRATEDFIXATIONSYSTEM - COFEPRIS Registration 515C2022 SSA
Access comprehensive regulatory information for SPIRA®-CINTEGRATEDFIXATIONSYSTEM (SPIRA-CINTEGRATEDFIXATIONSYSTEM®) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 515C2022 SSA and manufactured by EMERGO,S.DER.L.DE C.V.. The device was registered on June 21, 2022.
This page provides complete registration details including product type (II. PROSTHESES, 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.
ELSISTEMADEFIJACIÓNINTEGRADOSPIRA-CDECAMBERSPINE TECHNOLOGIES CONSTA DE UN DISPOSITIVOINTERCUERPO INDEPENDIENTE INDICADO PARA USO ENUNO O DOS NIVELES CONTIGUOS DE LA COLUMNAVERTEBRALCERVICAL,DESDE ELDISCO C2-C3HASTA ELDISCO C7-T1, EN PACIENTES CUYO ESQUELETO HAYAALCANZADO LA MADUREZ, Y QUE HAYAN RECIBIDOTRATAMIENTONOOPERATORIODURANTESEISSEMANASPARA LA ENFERMEDAD DE DISCO CERVICAL. LAENFERMEDAD DE DISCO CERVICAL SE DEFINE COMORADICULOPATÍA Y/O MIELOPATÍA RESISTENTE(S)
THE SPIRA-CDECAMBERSPINE TECHNOLOGIES INTEGRATED FIXATION SYSTEM CONSISTS OF A STAND-ALONE INTERBODY DEVICE INDICATED FOR USE ON ONE OR TWO CONTIGUOUS LEVELS OF THE CERVICAL SPINE, FROM THE C2-C3HASTA DISC TO C7-T1, IN PATIENTS WHOSE SKELETON HAS REACHED MATURITY, AND WHO HAVE RECEIVED NONOPERATIVE TREATMENT FOR SIX WEEKS FOR CERVICAL DISC DISEASE. CERVICAL DISC DISEASE IS DEFINED AS RADICULOPATHY AND/OR RESISTANT MYELOPATHY(S)