Número da Revisão
Rev.00
Data de Expiração
20/10/2028
Descrição
Scope: Design and manufacture of surgical instruments, external fixators, and sterile and non-sterile implantable medical devices for hip, knee, and shoulder arthroplasty; craniomaxillofacial osteosynthesis, extremities, and traumatology; spine and sports medicine. Distribution of cement and implantable bone substitutes, and surgical instruments.
Norma
ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009.
Status
Ativo