Número da Revisão
Rev.02
Data de Expiração
15/06/2026
Descrição
“Scope: Design, development, manufacturing, sales and distribution of:
– Non-sterile implants for osteotomy and traumatology (upper and lower limbs) and cranio-maxillofacial;
– Non-sterile reusable surgical instruments for osteotomy, traumatology (upper and lower limbs) support and
craniomaxillofacial.
– Sterile disposable surgical instruments (ETO) with coated for: craniomaxillofacial, upper and lower limbs coated with
diamond and/or DLC, craniomaxillofacial for traumatology, arthroplasty and maxillofacial coated by DLC Black or
Diamond;
– Sterile surgical instruments (ETO) for surgical support on osteotomy, traumatology (upper and lower limbs) and
craniomaxillofacial;
– Disposable temporomandibular joint (ETO);
– Sterile implants (ETO) with applicator (disposable) with wire and anchor for reconstruction of soft tissue;
– Sterile implants (ETO) with disposable applicator Button, wire and plate for fixation of fragments on syndesmotic
fractures;
– Sterile implants (ETO) without disposable applicator with wire and plate for reconstruction of anterior cruciate ligament.
– Sterile prothesis (ETO) for arthroplasty of partial elbow;
– Sterile implants (ETO) for fixation of various bone fractures.”
Norma
ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009
Status
Ativo