Mexico COFEPRIS registration 257C2019 SSA

SISTEMA DE FIJACIÓN INTERESPINOSO NOVAXDMA

EN: NOVAXDMA INTERSPINOUS FIXATION SYSTEM
Mexico flagMexico·Clase III·II. PROSTHETICS, ORTHOSES AND FUNCTIONAL AIDS·MANDALA MÉXICO LEGAL AFFAIRS, S.A. DE C.V.·Registered February 12, 2019
Product Use / Uso del Producto
Spanish

EL DISPOSITIVO ESTÁ INDICADO PARA: • ENFERMEDAD DEGENERATIVA DISCAL: HERNIA DISCAL, DOLOR ARTICULAR ARTRÓSICO, INESTABILIDAD SEGMENTARIA • CONDUCTO RAQUÍDEO ESTRECHO: ARTRÓSICO: CENTRAL O LATERAL POR ESPONDILOLISTESIS DEGENERATIVA. • ESTENOSIS FORAMIN

English

THE DEVICE IS INDICATED FOR: • DEGENERATIVE DISC DISEASE: HERNIATED DISC, ARTHRITIC JOINT PAIN, SEGMENTAL INSTABILITY • NARROW SPINAL CANAL: ARTHRITIC: CENTRAL OR LATERAL DUE TO DEGENERATIVE SPONDYLOLISTHESIS. • FORAMIN STENOSIS

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)
SISTEMA DE FIJACIÓN INTERESPINOSO PARA COLUMNA VERTEBRAL DE POLIÉTER ÉTER CETONA (PEEK)
Trade Name (English)
INTERSPINOUS FIXATION SYSTEM FOR POLYETHER ETHER KETONE (PEEK) SPINE
Registration information
Analysis ID
257C2019 SSA
Registration Date
February 12, 2019
Manufacturer / Fabricante
Name (English)
MANDALA MÉXICO LEGAL AFFAIRS, S.A. DE C.V.
About this record

Access comprehensive regulatory information for SISTEMA DE FIJACIÓN INTERESPINOSO NOVAXDMA (NOVAXDMA INTERSPINOUS FIXATION 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 257C2019 SSA and manufactured by MANDALA MÉXICO LEGAL AFFAIRS, S.A. DE C.V.. The device was registered on February 12, 2019.

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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