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Ortomedic implants fall foul of Brazilian product registration

This article was originally published in Clinica

Executive Summary

Trading in four orthopaedic devices marketed in Brazil by Ortomedic Distribuidora de Implantes Ortopédicos has been suspended for not fulfilling the product registration and/or re-registration requirements, says national regulatory agency Anvisa. They are: Spacevision Acif, Sistema Espinhal Toracolombar Vers�til Uni-Thread, Sistema Universal de Ligação de Eixo Plus and Spacevision Plif, according to an alert notice posted on September 17. A formal notice issued to Ortomedic on September 16 gives the São Bernardo do Campo, São Paulo firm 30 days to provide the missing "economic information", as required under Resolution RDC 185, of October 2006.

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